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Risedronic Acid

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Alendronic Acid

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J P N Pharma founded in 1988 with a plant at Tarapur, India, as a manufacturer of Active Pharma Ingredients (API's) and Drug Intermediates (DI's) to fulfill the needs of domestic as well as global customers in the field of Pharma.ISO & Indian GMP compliant & WHO GMP is under process.+ Read More

Nature of Business

Manufacturer

Year of Establishment

1988

Legal Status of Firm

Limited Company (Ltd./Pvt.Ltd.)

GST Number

27AABCJ4911B1Z2

Risedronic Acid
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Risedronic Acid

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CAS No: 105462-24-6
Chemical Name [1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic acid
Molecular formula C7H11NO7P2
Molecular Weight 283.11
Test Specification
Description White to off white Crystalline powder
Identification A) Infra Red Absorption Spectrum
Solubility Soluble in 0.1 M sodium hydroxide, Sparingly soluble in water, insoluble in organic solvents
Clarity & colour of solution (1% w/v in water) Clear & Colourless solution
pH (1% in Water) Limit : 3.7 ? 4.8
Loss on Drying Limit : 12.2% - 13.5% w/w/
Heavy Metals Limit : Max. 20 ppm
Residual Solvents
Monochloro Benzene
Methanol
Chloroform Limit :
2000 ppm
1500 ppm
1000 ppm
Related Substances
a) Pyridine ? 3-actic acid (by HPLC)
b) Phosphite content (by tritrimetic Max. 0.2%
Max. 1%
Assay % (by HPLC) (On anhydrous basis) Limit : Min. 99%

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Alendronic Acid
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Alendronic Acid

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CAS No. 66376-36-1
CAS Name (4-Amino-1-hydroxybutylidene)bisphosphonic acid
Additional Name a-hydroxy-d-aminobutylidenediphosphonic acid
Molecular wt. 249.10
Chemical Composition C H NO P
4 13 17 2
Test Specification
Description White Crystalline Powder
Identification A. I. R. TEST
Heavy Metals Limit : Max .20PPM
Loss on Drying (By Kf) 1% W/W
4-Aminobutanoic acid (by TLC) Limit : Max.0.5%
Phosphite Limit : Max.0.5%
Assay (Titration) Limit: 98% to 102%

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Aminobutanoic Acid

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Specification 4- Amino butyric Acid OR 4- Aminobutanoic Acid
CAS. NO. [56-12-2 ]
Molecular Formula C4H9NO2
Molecular Weight 103.12
Test Specification
Description White crystalline powder.
Identification Chemical Test
Clarity of Solution It should be clear
pH Limit : 6.5 -7.5
Heavy Metals Limit : Max. 10 PPM
Chloride Limit : Max. 40 PPM
Sulphate Limit : Max.50 PPM
Arsenic Limit : Max. 1 PPM
Ca2+ No Opalescence
Melting Point Limit : 1970 C - 2040C
Loss of Drying Limit : Max. 0.5%
Residue on Ignition Limit : Max. 0.1%
Assay Limit : Min. 99%

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Ibandronic Acid

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Specification Ibandronic Acid
Test Specification
Description White flowing powder
Solubility Soluble in water, slight soluble in methanol
Clarity of Solution Colourless, Clarify
Heavy Metals Limit : Max. 20PPM
Phosphite Limit : Max. 0.3%
Phosphate Limit : Max. 0.3%
Relative Substance Any single impurity : Max. 0.3% Total Impurity : Max. 1%
Assay Limit : 98% to 102%

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Propionic Acid

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Specification 3-(N-methylpenthylamino) propionic acid HCL
CAS No. 625120-81-2
Chemical Composition C9H19NO2 HCl
Test Specification
Description White Crystalline or crystalline Powder
Melting Point Limit : 980 -1000C
Relative Substance Total Impurity : Max. 0.5% Any single impurity : Max. 0.2%
Residue on ignition Limit : Max.0.2%
Loss on Drying Limit : Max. 0.2%
Assay Limit: Min.99%

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Benzil

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Specification Benzil
Test Specification
Description Light yellow crystals
Solubility Passes in Ethanol
Melting Point Limit: 93 0 C to 96 0 C
Tlc Passes in single spot
Extra Tests Performed On Benzil
In 50 % Solution of Caustic Soda No suspended impurity seen after half an hour of string (clear water white solution)
In Susphuric Acid 0.10 gms in 5 ml shows light yellow colour for the hour (no green colour or blue colour found)
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Benzilic Acid

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Specification Benzilic Acid
CAS NO 76-93-7
Molecular Formula C H O
14 12 3
Molecular Weight 228.24
Synonym {Hydroxy {Phenylbenzene Acetic Acid Or Diphenylalycolic Acid}
Test Specification
Description Almost white crystalline powder, odourless, taste bitter
Solubility Slightly soluble in cold water, Highly soluble in hot water, Alcohol, Ether
Melting Point Limit: 148 0 Cto 150 0 C
Loss On Drying Max. 1.0 %
Sulphated Ash Max. 0.1 %
Chloride (CL) Max. 0.01 %
Sulphate (SO) 4 Max. 0.02 %
Assay Min. 98.0 %

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Heptanoic Anhydride

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Specification Heptanoic Anhydride
CAS NO 626 - 27 - 7
Extended Formula [CH3(CH2)5CO]2O
Empirical Formula C14H26O3
Formula Weight 242.36
Test Specification
Description Very faintly yellow clear liquid
Solubility Colourless, Clear
Solubility (Method) 1 G in 10 ML ETOH
Iodine Value Limit : Max.1 %
Free Acidity As (Heptanoic Acid) Limit : Max.1.5 %
Density D 25 0.905
Assay Limit : Min.98 %

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Ethanone

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Specification 1-(6-Methylpyridine-3-yl)-2{(4-methylsulphonyl)phenyl]ethanone (ketosulphone)
Test Specification
Description White to creamish powder
Melting Point 180°C – 186 °C
Water content NMT 0.5 %
Assay by HPLC NLT 93.0 %
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Specification 2-CHLORO-1,3-BIS(DIMETHYLAMINO)TRIMETHINIUM HEXAFLUOROPHOSPHATE
Test Specification
Description Cream to pale yellow crystalline Powder.
Melting Point Limit 120 ° C to 130 ° C
Water content NMT 0.5 %
Chromatographic Purity by HPLC NLT 98.00 %

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Benzoin

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Specification Benzoin
Chemical Name Acetophenone, 2-Hydroxy-2-Phenyl Or
Ethanone, 2-Hydroxy-1, 2-Diphenyl Or
A-Hydroxy-A-Phenylacetophenone
CAS No. 119-53-9
Formula C14H12O2
Test Specification
Description Creamish crystalline
Solubility Soluble in Acetone
Melting Point Limit 132 0 Cto 136 0 C
TLC Single spot
Chromatography Purity :-
Single Maximum Impurity Limit : Max. 1 %
Total Impurity Limit : Max. 3 %
Loss on Drying w/w Limit Max. 1%
Assay (by G.C) Above 97%

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N-Caproic Anhydride

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Specification N - Caproic Anhydride
Synonym Hexadecanoic Anhydride
CAS No. 2051-49-2
Extended Formula [CH3 (CH2)4CO] 20
Empirical Formula C12H22O3
Test Specification
Description Very faintly yellow clear liquid
Acid Value (As Free Caproic Acid) Limit: Max.1%
Iodin Value Limit: Max. 1 %
Density D (20/4) Limit : 0.920 to 0.928
Reflective Index N (20/D) 1.429
Assay Limit: Min.97%

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Gallic Acid

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Specification Gallic Acid
Test Specification
DESCRIPTION White to off white crystalline powder.
SOLUBILITY One gm dissolves in 87ml water, 3ml boiling water, 6ml alcohol, 100 ml ether, 10ml glycerol, 5 ml acetone, practically insoluble in benzene chloroform, pet. ether.
MELTING POINT Limit : 258-265°C
ARSENIC Limit : NMT 4 PPM
RELATED SUBSTANCE(TLC) Complies.
LOSS ON DRYING Limit : Max. 10% w/w (for Monohydrate) & Max. 1% w/w (for anhydrous)
RESIDUE ON IGNITION Limit : Max. 0.1%
HEAVY METALS Limit : NMT 20 PPM
PURITY BY ACID TITRATION Limit : Min. 99.5%

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Methyl Gallate

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Test Specification
Description White crystalline powder, odourless
Impurities Complies as single spot seen in TLC (No unconverted Gallic Acid spot)
Solubility Soluable in hot water Alcohol, Menthanol & Ether
Melting Point Limit: 2020 C
TLC Single spot
Chromatographic Complies
Assay Limit: Min. 98%

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Heptanoic Anhydride

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CAS NO 626- 27- 7
EXTENDED FORMULA (CH3(CH2)5CO)2O
EMPIRICAL FORMULA C14 H 2605
FORMULA WEIGHT 242
APPEARANCE VERY FAINTLY YELLOW CLEAR LIQUID
ASSAY MINIMUM 98%
IODINE VALUE 1%
FREE ACID 1.50%
DENSITY D 25 0.905
SOLUBILITY COLOURLESS CLEAR
SOLUBILITY (METHOD) 1 G IN 10 ML ETOH

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Trimethoxy Benzaldehyde

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Specification 2,3,4-Trimethoxy Benzaldehyde
CAS No. 2103-57-3
Molecular Formula (CH30)3C6H2CHO
Molecular Weight 196.20
Test Specification
Description Off white to pale yellow crystalline powder
Solubility Should be soluble in MDC and toluence
Melting Range Limit : 390C to 420C
Moisture by KF Max. 0.5%
Assay (by GC) Limit :Min. 99%
Storage Store in air tight containers
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Specification Potassium Hydroxide Powder
Test Specification
Caustic Potash as KOH Limit :Min. 87%
Potassium Carbonates (AS K2CO3) Limit : Max. 1%
Potassium Chlorides (AS KCL) Limit : Max. 300 PPM
Iron as Fe+++ Limit : Max. 20 PPM
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Silver Nitrate

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Specification Silver Nitrate
Test Specification
Description White crystalline Powder.
Solubility Freely soluble in water
Water Insoluble matter Limit : 0.003%
Chloride Limit : 0.0005%
Sulphate Limit : 0.0025%
Bismuth Limit : 0.0005%
Calcium Limit :0.001%
Copper Limit : 0.0002%
Iron Limit : 0.003%
Lead Limit : 0.0005%
Magnesium Limit : 0.001%
Potassium Limit : 0.01%
Sodium Limit : 0.002 %
Loss On Drying Limit : 0.01%
Assay Limit : Min. 99.9%

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Ethylene Urea

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Certificate of Analysis Ethylene Urea (Anhydrous)
Test Specification
Description White to pale yellow free flowing powder.
Alkalinity as Free EDA Limit: Max.0.1%
Melting Point Limit : Min. 1310 C
PH of 10 % Aqueous Solution Limit : Limit: 6.0 ? 8.0
Total Moisture Limit : Max. 1%
Water Insoluble Limit: Max 0.05%

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N-Acetyl Ethylene Urea

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Specification N- Acetyl Ethylene Urea
CAS No. 5391-39-9
Molecular Formula C5H8N2O2
Molecular Weight 128
Test Specification
Description White to straw crystalline powder.
Solubility Soluble in methanol
Melting Range Limit: 175 0 C to 184 0 C

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Pio Imino Compound

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Molecular Formula C19H21N3O2S
Molecular Weight 355.45
Test Specification
Description Off white to buff yellow solid.
Identification (By HPLC) The retention time of the principal peak (Imino Compound Peak) obtained with sample solution is corresponds to that of standard solution as obtained in Assay
Melting Point Limit : 180 0 C to 195 0 C
Related Substances
1) Any Single Impurity
2) Total Impurities Limit : Max. 3.0%
Max. 0.5%
Loss on drying Limit: Max. 1.00% w/w
Assay
(On Dried Basis)
(By H.P.L.C.) Limit: Min. 95%

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Aminobutanoic Acid

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Specification 4- Amino butyric Acid OR 4- Aminobutanoic Acid
CAS. NO. [56-12-2 ]
Molecular Formula C4H9NO2
Molecular Weight 103.12
Test Specification
Description White crystalline powder.
Identification Chemical Test
Clarity of Solution It should be clear
pH Limit : 6.5 -7.5
Heavy Metals Limit : Max. 10 PPM
Chloride Limit : Max. 40 PPM
Sulphate Limit : Max.50 PPM
Arsenic Limit : Max. 1 PPM
Ca2+ No Opalescence
Melting Point Limit : 1970 C - 2040C
Loss of Drying Limit : Max. 0.5%
Residue on Ignition Limit : Max. 0.1%
Assay Limit : Min. 99%

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Propionic Acid

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Specification 3-(N-methylpenthylamino) propionic acid HCL
CAS No. 625120-81-2
Chemical Composition C9H19NO2 HCl
Test Specification
Description White Crystalline or crystalline Powder
Melting Point Limit : 980 -1000C
Relative Substance Total Impurity : Max. 0.5% Any single impurity : Max. 0.2%
Residue on ignition Limit : Max.0.2%
Loss on Drying Limit : Max. 0.2%
Assay Limit: Min.99%

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Sodium Alendronate

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Specification Sodium Alendronate BP or 4-Amino 1-Hydroxy Butylidene Bis Phosphonic Acid Mono Sodium Salt Tri Hydrate
Test Specification
Description White crystalline powder, Odourless, Tasteless
Identification A) I. R. Test should complies with IR of standard.
Solubility Soluble in water very slightly soluble in Methanol, practically insoluble in Methylene Chloride
Appearance of Solution Clear and colour less solution
Heavy Metals Limit: Max.20 PPM
Ph (1% Solution) Limit between 4.0 to 5.0 (0.5 Gms in 50 ML Water)
4 - Amino Butyric Acid (By TLC) Limit: Max.0.5%
Phosphate and Phosphite (By H.P.L.C.) Limit: Max.0.5%
Loss on drying (at 140° C to 145°C) Limit: 16.1% to 17.1%
Assay
(On Dried Basis)
(By H.P.L.C.)
(By Titration) Limit: 98% to 102%

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Bisacodyl Bp

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Specification Bisacodyl BP / USP
Test Specification
Description White Crystalline Powder
Solubility
Practically insoluble in water, soluble in acetone, sparingly soluble in alcohol, slightly soluble in ether. It dissolves in dilute mineral acids
Identification A) Melts between 131°C- 135°C
B) U.V. Absorption.
C) IR
D) TLC- Complies.
Acidity or Alkalinity NMT 0.4 ml of 0.01M HCl required to change the colour.
Related substance(TLC) Should be single spot
Sulphated Ash Limit : Max. 0.1%
Loss on Drying [100°C-105°C] Limit : Max. 0.5%
Assay Limit: 98 % to 101%
(On Dried Basis)

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Eosin Yellow Sodium Salt

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Specification Eosin Yellow Sodium Salt FRP
Test Specification
Description Brownish red powder
Identification A. Test Passes
B. Test Passes
C. Test Passes
D. Test Passes
E. Test Passes
Solubility 0.1 %( In Water) Clear reddish yellow solution
Absorptivity (A1%,1CM WaterAlphamax) Limit :1200-1400
Absorption Maximum (Water Alpha max) Limit : 515-518 NM
Combined ether extracts Mass of residue : Max.0.5%
Related Substances Complies
Chloride Limit : Max. 1%
Sulphated Ash Limit : 20 to 23%
Insoluble Matter Limit : Max 0.2 %
Loss On Drying (At 1100C 1HR) Limit : Max 8%
Ether Limit : Max.0.5%
Assay Limit : Min. 87 %
pH (a 2% solution in distilled water) Limit : 7.0 to 8.0
Lead (as Pb) Limit : Max. 20 PPM
Arsenic (as As) Limit : Max. 3 PPM

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Methylene Blue

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Methylene Blue BP / USP
C.I. No. 52015
CAS No. 61-73-4
Test Specification
Description Dark greenish powder
Identification A) Test passes
B) Test passes
C) Test passes
D) Test passes
Solubility 0.1% (Water) Clear Blue Solution, Soluble in water, slightly soluble in Alcohol, practically insoluble in Ether
Absorptivity 1%, 1cm, at λ Max. 664.0nm Limit : 2200-2750
Methanol Insoluble Substances Limit: Max.1.0%
Related Colorants As per EP
Heavy Metals Limit: Max. 20PPM
Iron Limit : Max.100PPM
Zinc Limit: Max.100PPM
Loss On Drying (At 110° C) Limit: 10-15%
Sulfated Ash Limit : Max. 0.25%
Assay Limit: 95% to 101%
(On Dried Basis)

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Phenytoin Base

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Phenytoin Base B. P
Specification Phenytoin Base B. P
Test Specification
Description Almost white crystalline powder, odourless
Identification A) I. R. Test passes
B) T.L.C. Test Passes
C).Test Passes
D).Test Passes
Solubility Practically insoluble in water, sparingly soluble in alcohol, very slightly soluble in Methylene chloride
Clarity And Color of Solution Clear & colorless solution
Acidity Or Alkalinity As per B.P.
Related Substance As per B.P.
Heavy Metals Limit: 10 PPM
Loss On Drying Limit : Max. 0.5%
Sulphated Ash Limit :Max. 0.1%
Assay Limit: 99 % to 101%

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Sodium Bp

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Phenytoin Base / Sodium BP / EP
Specification Phenytoin Base / Sodium BP / EP
Test Specification
Description A white, crystalline power, hygroscopic
Identification A) I. R. Test passes
B) Test passes
C) Test passes
Clarity And Colour of Solution As per BP
Heavy Metals Limit: Max.10 PPM
Free Phenytoin Limit : 0.1 normal NaoH Sodium Hydroxide
Related Substance/TLC By TLC Passes
Water Content Limit : Max. 3.0%
Assay Limit : 98.5% to 100.5%
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Sodium Picosulfate Bp

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Specification Sodium Picosulfate BP
Test Specification
Description A white or almost white crystalline powder
Identification A) I. R. should confirm
B) TLC as per Related Substance
C)Chemical Test
D) Chemical Test
E) Gives reaction of Sodium
Solubility Freely soluble in water, slightly soluble in alcohol
Appearance of Solution The solution should clear and not more intensely colored than reference solution GY7
Acidity Or Alkalinity The solution is colourless. NMT 0.25 ml of 0.01 M NaOH is required to change the colour of the indicator of peak
Related Substance Limit : Max. 0.2%
Chloride Limit : Max. 200 PPM
Sulphate Limit : Max. 400 PPM
Heavy Metals Limit: Max. 1 PPM
Water Content Limit : 3.0% - 5.0%
Assay O.D.B. (by Titration) Limit: 98.5 % to 100.5%

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Propyl Gallate

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Specification Propyl Gallate B.P
Test Specification
Description White or almost white crystalline powder
Identification A) Melting point : Limit :1480C to 1510C
C) TLC for Gallic Acid
D) Chemical test
Solubility Very slightly soluble in water, freely soluble in ethanol (96%). It dissolves in dilute solution of Alkali hydroxide.
Appearance of solution 5% w/v solution of sample in alcohol is clear.
Gallic acid Limit : Max. 0.5%
Chlorine Limit : Max.200 PPM
Total Chloride Limit : Max.100 PPM
Zinc (Atomic Absorption Spectrometry) Limit : Max. 25 PPM
Heavy Metals Limit : Max.10 PPM
Loss on drying Limit: Max. 0.5%
Sulphated Ash Limit : Max..0.1 %
Assay Limit: 97% to 103%

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Silver Sulphadiazine

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Specification Silver Sulphadiazine U.S.P.
Test Specification
Description Fine white powder
Identification A) I. R. Test passes
B) T.L.C. Passes
C) Passes
Chromatographic Purity Sum of all secondary spots is Max. 2%
Nitrate Limit: Max.0.1 %
Particle Size Limit : Less than 10 microns
Loss on drying (At 105 0 C) Limit ; Max. 0.5 %
Sulphadiazine Content Limit : Around 70%
Silver Content Limit : Between 29.3 % to 30.5 %
Assay Limit:98% to 102%
(On Dried Basis)
(By H.P.L.C.)

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Tizanidine Hydrochloride

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Specification Tizanidine Hydrochloride U.S.P
Test Specification
Description A white to off white crystalline powder.
Solubility Soluble in water and methanol, practically insoluble in acetone, chloroform, ethyl acetate.
Identification
A) IR Spectrum IR absorption spectrum of sample in KBR dispersion is concordant with that of reference standard of Tizanidine HCl
B) HPLC The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the assay.
pH (A 1% w/v aqueous solution) Limit between 4.3 to 5.3
Loss On Drying (At 105 0 FOR 3 HRS) NMT 0.5 % w/w
Residue on Ignition NMT 0.1% w/w
Heavy Metals Not more than 0.002%
Related Substance (HPLC)
Tizanidine related compound C
Tizanidine related compound B
Tizanidine related compound A
Individual unknown impurity Total impurities Not more than 0.1%
Not more than 0.1%
Not more than 0.1%
Not more than 0.1%
Not more than 0..3%
Organic volatile impurities Meets the requirement
Content of Chloride NLT 11.9% & NMT12.5%
Assay (By Titration) (On Dried Basis) Limit: 98.0 % TO 102.0 % w/w

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Risedronate Sodium

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Chemical Name Sodium Salt of [1-Hydroxy-2-(3-pyridinyl)ethylidene] bisphosphonic acid
CAS No: 115436-72-1
Molecular Formula C7H10NNaO7P2
Molecular Weight 305.11
Merck Index No. 8315
Test Specification
Description White to off white Crystalline powder
Identification A) I.R. absorption Spectrum
Solubility Soluble (1%) in 0.1 M sodium hydroxide, Sparingly soluble in water, very slightly soluble in ethanol and in dimethyl formamide.
Clarity and colour of solution (1% w/v in 0.1N NaOH) Clear and colourless
pH of a 1% in w/v solution in Water Limit : 4.2 ? 5.2
Loss on Drying Limit : 11.5% - 13.5%
Heavy Metals Limit : Max. 20 PPM
Related Substances
a) Pyridine ? 3 acetic acid (by HPLC)
b) Phosphite content (by titrimetry) Limit : Max. 0.25
Max..1.0
Assay (by HPLC) (On anhydrous basis) Limit : 98.0% to 102.0%

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Tizanidine Chemical

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Specification Tizanidine HCl USP
Chemical Name 5-Chloro-4-(2-imidazolin-2-ylamino) -2,1,3-benzothiadiazole 5 chloro-N-(4,5- dihydro-1H-imidazol-2-yl)-2,1,3- benzothiadiazole hydrochloride.
CAS. NO. 064461-82-1
Molecular Formula : C9 H8cl N5,-Scl-H
Molecular Wt. 290.18

Test Specification
Description Creamy white to yellowish white powders
Identification
A) IR Spectrum IR absorption spectrum of sample in KBR dispersion is concordant with that of reference standard of Tizanidine HCL
B) UV Spectrum UV absorption spectrum of 0.001% w/v solution of sample in water shows two maximum at 320 + 2 NM & 227 + 2 NM respectively
C) Reaction Of Chloride Responds to test of chloride
Solubility Soluble in H2O, and methanol slightly soluble in ethanol, practically insoluble in chloroform ethyl acetate & ether.
Clarity Of Solution A 5% w/v solution in water of sample at should be clear
Colour Of Solution A 1 % w/v solution in water of sample at 420 NM with a 1 cm path length shows an absorbance of not more than 0.025 au
Ph (A 5% W/V Aqueous Solution) Limit between 3.5 to 5.0
Melting Range 286 to 290 0 C with decomposition
Sulphated Ash Limit : Max. 0.1% w/w
Loss On Drying (At 105 0 FOR 3 HRS) Limit: Max. 0.5 % w/w
Heavy Metals Limit : Max. 20 PPM
Chromatographic Purity (By HPLC) Limit: Min 99% w/w
Single impurity : Max.0.2%
Total impurity : Max. 0.5%
Assay (On Dried Basis) Limit: 98.5 % TO 101.0 % w/w

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Trimetazidine Chemical

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Specification Trimetazidine HCl JP / BP / EP
Chemical Composition C14H22N2O3.2HCl
Molecular wt. 339.26
Test Specification
Description A white Crystalline Powder, Slightly hygroscopic.
Solubility Soluble in water, sparingly soluble in ethanol & practically insoluble in ether
Identification A) Test Passes
B) Test Passes
Heavy Metals Limit: Max. 20 PPM
Arsenic Limit :Max.2PPM
Ph of Solution ( 1 in 20) Limit : 2.3 to 3.3
Clarity And Colour of the Solution Clear and Colourless Solution
Melting Point Limit : 225o to 227o
Residue on Ignition Limit : Max. 0.2 %
Loss on drying Limit : Max.:2%
Assay Limit: Min. 98%

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Ibandronate Sodium

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Specification Ibandronate Sodium
Chemical Name 1 Hydroxy 3(N ) Methly 3(N) n Pentylamino,1,1 Bisphosphonic Acid
Molecular Formula C9H22O7NP2NaH2O
Molecular Weight 359.17
Test Specification
Description White crystalline powder
Solubility Soluble in water, not soluble in alcohol
Loss on Drying Limit : 4.5% - 8.5%
Chloride Limit : Max. 0.005%
Sulphate Limit : Max. 0.005%
Heavy Metals Limit : Max. 0.001%
Related Substance Limit : Max. 0.5%
Phosphite Limit : Max. 0.3%
Assay (By HPLC) Limit : Min. 99.5%

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Fosphenytoin Sodium

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Specification :Fosphenytoin Sodium USP
Test Specification
Description A white or almost white crystalline powder
Identification A) IR
B) The retention time of peak obtained in the chromatogram of the Assay preparation responds to that in the chromatogram of the standard preparation obtained in the test of assay
C) Test for Sodium
pH Limit : Between 8.5-9.5
Water Limit : Between 21.7%-25.7%
Heavy Metals Limit : Max. 0.002%
Chromatographic Purity (BY HPLC) Max. 0.1% of Phenytoin is found
Max. 0.1% of the other impurity is found
Max. 0.5% of the total impurities is found
Organic Volatile Impurities Meets the requirements
Assay (BY HPLC) [on anhydrous basis] Limit : 98% - 102%

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Fluorescein Sodium

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Specification Fluorescein Sodium USP
C. I. Name Acid Yellow 73
C.A.S. No. 518-47-8
C. I. No 45350

Test Specification
Description A Browinsh Orange powder. Al most odourless and hygroscopic in nature.
Absorption Maxima (Buffer = 8) max Limit : 490-492 n m
Absorptivity (A1%,1 CM in Buffer = 8 at max ) Limit : 2050-2200
Solubility of 2 %Solution IN D.W. Clear and Orange, Exhibits Yellowish Green Fluorescence
pH (2% Soltn IN D.W.pH=7) Limit : 7 - 9
Loss on Drying (AT 135 0 C For 1 HR.) Limit : Max. 5 %
Chloride Limit : Max. 1%
Sulphate Limit : Max. 1 %
Sulphated ASH Limit : 33.5-35 %
Zinc Limit : Max. 0.1 %
Lead Limit : 10 PPM
Arsenic Limit : 3 PPM
Mercury Limit : 1 PPM
Iron Grade Not More Than 8 Small Iron Particles on Hand Magnet
Particle Size 100 % Pass Through 100 Mesh Size

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Pioglitazone Chemical

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Specification Pioglitazone HCl IP / BP
Chemical Name 5-[4-[2-(5-ethyl-2 pyridyl) ethoxy] benzyl] -2,4 thiazolidinedione hydrochloride
Test Specification
Description White to off white powder
Identification A) IR Test should concordant with IR of Standard.
B) Gives Reaction of Chloride.
Solubility Soluble in dimethyl formamide, Slightly
soluble in anhydrous Ethanol, very slightly
soluble in Acetone and Acetonitrile, practically insoluble in ether and in water
Residue on Ignition Limit: Max. 0.2%
Melting Point Limit: 193-1960C
Heavy Metals Limit: Max. 20 PPM
Loss on Drying (at 1050C, 3hr) Limit: Max. 0.5%w/w
Related Substances (HPLC) Individual Impurity Total Impurity Limit: Max. 0.5%
Limit: Max. 1.0%
Assay (HPLC) (On Dried Basis) Limit: 98.0%-101.5%

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Pamidronate Disodium

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Specification Pamidronate Disodium
Chemical Name Disodium Dihydrogen(3-Amino-1- Hydroxy Propylidene) Bisphosphonate Pentahydrate
Test Specification
Description White or almost white crystalline powder
Solubility Soluble in water, practically insoluble in methylene chloride. It is sparingly soluble in dilute minerals acids and dissolves in dilute alkaline solutions.
Identification A) Infrared absorption spectrophotometry
B) Gives reaction of sodium.
Appearance of solution The solution is clear and not more intensely coloured than reference solution Y6.
pH ( 1% w/v in water) pH ( 1% w/v in water)
Impurity A Limit : Max. 0.5%
Impurity B & C Limit : Max. 0.5%
Heavy Metals Limit : Max. 20 PPM
Water Limit : Between 23% - 27%
Assay (On anhy. basis) Limit : 98 % to 101%

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Amlodipine Besilate

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Specification Amlodipine Besilate BP / EP
Test Specification
Description White or almost white powder
Identification A) Infrared Absorption spectrophotometry
B) TLC
C) Specific Absorbance Max 360 nm 113-121
Solubility Slightly soluble in water, freely soluble in Methanol, sparingly soluble in ethanol, slightly soluble in 2-propanol.
Optical Rotation - 0.10 0 to + 0. 10 0
Related Substance by
1) TLC
2) Liquid chromatography
a. Impurity D
b. Other Impurities It should complies as prescribed test
a. Max. 0.3%
b. Max. 0.3%
Water Limit: Max. 0.5%
Sulphated Ash Limit : Max. 0.2%
Assay (Anhydrous basis) Limit: 97% to 102%
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