Description	Brown colored powder having characteristic odor and taste
Identification	Positive for fluvic acid
pH of 1 % aqueous soln.	6 – 7
Extractive value in 1 % w/v solution in water	NLT 70 %
Loss on drying at 105° C	NMT 5 %
Ash content	NMT 10 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 10000 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay as Fluvic acid	NLT 1 %

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Bacopa Monnieri Dry Extract

Description	Brownish green colored powder
Identification	Positive for bacosides
pH of 1 % aqueous soln.	7 – 9
Extractive value in water	NLT 50 %
Extractive value in 50 % v/v methanol solution	NLT 50 %
Loss on drying	NMT 8 %
Ash content	NMT 25 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 10000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay (Total Saponin content on dry basis)	NLT 45 %

Banaba Dry Extract

Description	Dark brown having characteristic odour and taste
pH of 1 % aqueous soln.	5 – 7
Extractive value in water	NLT 60 %
Extractive value in 60 % v/v methanol solution	NLT 50 %
Loss on drying	NMT 4 %
Ash content	5 – 7 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 10000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay (as crude corosolic acid on dry basis)	NLT 2 %

Calcium Sennoside Dry Extract

Description	Pale brown colour powder
Solubility	Soluble in water and Alcohol
Loss on drying	NMT 5 %
Heavy metals	NMT 10 ppm
Residue on ignition	NMT 15 %	NMT 20 %	5 – 8 %
Total microbial count	NMT 5000 CFU / gm
Molds and Yeast	NMT 100 / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
pH	6.3 – 7.5	6.3 – 7.3
Assay (Sennoside Content)	NLT 10 %	NLT 20 %	NLT 40 %

Docetaxel

Description	White to off white powder
Solubility	Soluble in Methanol
Identification	Positive test for Docetaxel
Water content by KF	NMT 4 % w/w
Chromatographic Impurities	NMT 1.0 %
Assay by HPLC (Anhydrous basis)	NLT 99% w/w

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Gymnema Sylvestre Dry Extract

Description	Light green or brown coloured powder
Identification	Positive for Gymnemic Acid
pH of 1 % w/v solution	5 – 7	4 - 6
Loss on drying	NMT 5 %	NMT 4 %
Total microbial count	NMT 5000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay ( Crude Gymnemic acid on dry basis)	NLT 25 %	NLT 75 %

Irinotecan Hydrochloride

Description	Pale Yellow to yellowish crystalline Powder
Solubility	Soluble in water and in organic solvents
Odour	Odorless
Identification
Test A	As per Inhouse specification
Test B	The retention time of the major peak in the chromatogram of sample preparation Corresponds to that in the chromatogram of the Standard preparation.
pH	3.0 – 5.0
Water	7.0 – 9.0 %
Chloride	3.0 – 5.5%
Heavy metals	NMT 0.002%
Residue on ignition	NMT 0.1%
Related Compounds By HPLC	Individual Impurity : NMT 0.5% Total Impurities : NMT 1.0 %
Assay	99 to 101 %

Kalmegh Dry Extract

Description	Dark brown colored powder
Particle size	90 % passes through 40 #
pH of 1 % aqueous soln.	6 – 8
Solubility in water	NLT 80 %
Loss on drying at 105° C	NMT 7 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 5000 CFU / gm
Molds and Yeast	NMT 100 / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay (Andrographolide content )	NLT 10 %	NLT 20 %	NLT 90 %

Karela Dry Extract

Description	Brown colored powder with bitter taste
pH of 1 % w/v solution	5 – 7
Extractive value of 1 % solution in water	NLT 90 %
Loss on drying	NMT 4 %
Ash content at 105°C	NMT 15 %
Total microbial count	NMT 5000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay ( Total bitter content on dry basis)	NLT 8 %

Paclitaxel

TEST	SPECIFICATIONS / LIMITS
Description	White to Off-white powder
Solubility	In-soluble in water and soluble in alcohol
Odour	Odourless
Identification
A. I R Spectrum C. HPLC	A. IR spectrum shall match with the IR of Reference Standard. C. The retention time of the major peak in the chromatogram of Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay
Specific rotation	between -49.0° and -55.0° at 20°
Microbial limits	As per USP
Bacterial endotoxins	Not more than 0.4 USP Endotoxin Unit per mg of paclitaxel
Water	Not more than 4.0 %
Residue on ignition	Not more than 0.2 %
Heavy metals	Not more than 0.002 %
Related Compounds By HPLC	(i) Individual Impurity NMT 00.10 % (ii) Total Impurities NMT 02.00 %

Topotecan Hydrochloride

Description	Light Yellow to Greenish Powder
Solubility	Soluble in water, methanol and dimethylformamide. Insoluble in ethanol
Odour	Odorless
Identification
Test A	As per Inhouse specification
Test B	The retention time of the major peak in the chromatogram of Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay
Melting point	213 – 218°C
Heavy metal	NMT 10 ppm
Residue on ignition	NMT 0.5 %
Related Compounds By HPLC	Individual Impurity : NMT 0.5% Total Impurities : NMT 1.0 %
Organic volatile impurities	As per specification
Assay	98 to 102 %

Tribulus Terrestries Dry Extract

Description	Brown colored powder having characteristic odor and taste
pH of 1 % w/v solution	4 – 6
Extractive value of 1 % solution in water	NLT 80 %
Loss on drying	NMT 5 %
Ash content at 105°C	NMT 15 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 5000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay ( Total saponin content on dry basis)	NLT 40 %

Tulsi Dry Extract

Description	Brown colored powder
Identification	Positive for Tanins
pH of 1 % w/v solution	4 – 6
Extractive value of 1 % solution in water	NLT 90 %
Loss on drying	NMT 5 %
Ash content at 105°C	NMT 20 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 5000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay ( Total tannin content on dry basis)	NLT 10 %

Tulsi Dry Extract

Description	Brown colored powder
Identification	Positive for Tanins
pH of 1 % w/v solution	4 – 6
Extractive value of 1 % solution in water	NLT 90 %
Loss on drying	NMT 5 %
Ash content at 105°C	NMT 20 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 5000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay ( Total tannin content on dry basis)	NLT 10 %

Tulsi Dry Extract

Description	Brown colored powder
Identification	Positive for Tanins
pH of 1 % w/v solution	4 – 6
Extractive value of 1 % solution in water	NLT 90 %
Loss on drying	NMT 5 %
Ash content at 105°C	NMT 20 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 5000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay ( Total tannin content on dry basis)	NLT 10 %

Tulsi Dry Extract

Description	Brown colored powder
Identification	Positive for Tanins
pH of 1 % w/v solution	4 – 6
Extractive value of 1 % solution in water	NLT 90 %
Loss on drying	NMT 5 %
Ash content at 105°C	NMT 20 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 5000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay ( Total tannin content on dry basis)	NLT 10 %

Tulsi Dry Extract

Description	Brown colored powder
Identification	Positive for Tanins
pH of 1 % w/v solution	4 – 6
Extractive value of 1 % solution in water	NLT 90 %
Loss on drying	NMT 5 %
Ash content at 105°C	NMT 20 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 5000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay ( Total tannin content on dry basis)	NLT 10 %

Tulsi Dry Extract

Description	Brown colored powder
Identification	Positive for Tanins
pH of 1 % w/v solution	4 – 6
Extractive value of 1 % solution in water	NLT 90 %
Loss on drying	NMT 5 %
Ash content at 105°C	NMT 20 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 5000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay ( Total tannin content on dry basis)	NLT 10 %

Tulsi Dry Extract

Description	Brown colored powder
Identification	Positive for Tanins
pH of 1 % w/v solution	4 – 6
Extractive value of 1 % solution in water	NLT 90 %
Loss on drying	NMT 5 %
Ash content at 105°C	NMT 20 %
Heavy metals	NMT 10 ppm
Total microbial count	NMT 5000 CFU / gm
Yeast and Mould count	NMT 100 CFU / gm
Pathogens
Staphylococcus aureus	Absent
Salmonella	Absent
Escherichia coli	Absent
Pseudomonas aeroginosa	Absent
Assay ( Total tannin content on dry basis)	NLT 10 %

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9,10-Dibromo Anthracene

9-Anthracene Methanol

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Quinine Sulphate

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Tolyl Sulfoxide

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