Sl. No.	Tests	Specifications	Reference
01.	Appearance	White, odorless or almost odorless, hygroscopic,crystalline powder.	USP
02.	Solubility		USP
03.	Identification A.Test for Calcium B. Test for Acetate.	Shall pass the test Shall pass the test	USP
04.	PH	6.3 to 9.6	USP
05.	Water	Not more than 7.0%	USP
06.	Linit of fluoride	Not more than 0.005%	USP
07.	Arsenic	Not more than 3 ppm	USP
08.	Heavy metals	Not more than 0.0025%	USP
09.	Lead	Not more than 0.001%	USP
10.	Chloride	Not more than 0.05%	USP
11.	Sulfate	Not more than 0.06%	USP
12.	Limit of nitrate	Shall pass the test	USP
13.	Readily oxidizable substances	Shall pass the test	USP
14.	Assay as C4H6CaO4 (On anhydrous basis)	99.0 % - 100.5%	USP

Sl. No.	Tests	Specifications	Reference
01.	Description	A white crystalline or granular powder	In-house
02.	Solubility	Freely soluble in boiling water	USP
03.	Identification	Shall pass the test	USP
04.	Chloride	Max. 500 ppm	USP
05.	Sulphate	Max. 500 ppm	USP
06.	Iron	Max. 40 ppm	USP
07.	Arsenic	Max. 3 ppm	USP
08.	Heavy metals	Max. 20 ppm	USP
09.	Clarity of 10% w/v solution	Should be clear to very slightly hazy	USP
10.	Colour of 10% w/v solution	98.0 % to 101.0 %	USP
11.	Calcium Content	7.5 % ± 0.5 %	USP
12.	Boric Acid Content	16 % ± 3 %	USP

Sl. No.	Tests	Specifications	Reference
01.	Description	White, odourless, crystalline powder.	USP
02.	Solubility	Slightly soluble in water; Freely soluble in diluted 3N HCl acid and diluted 2N nitric acid, insoluble in alcohol.	USP
03.	Identification A. Test A B. Test B	Shall pass the test Shall pass the test	USP USP
04.	Loss on drying	Between 10.0% and 13.3%	USP
05.	Arsenic	Max. 3 µg / g	USP
06.	Limit of fluoride	Max. 0.003%	USP
07.	Limit of acid – insoluble substances	Max. 0.2%	USP
08.	Lead	Max. 0.001%	USP
09.	Heavy metals	Max. 0.002%	USP
10.	Assay as Ca3 (C6H5O7) 2 on dry basis)	97.5% - 100.5%	USP

Product Name	:	Calcium Dobesilate Monohydrate EP
Molecular Formula	:	C12 H10 CaO10 S2.H2O
Molecular Weight	:	436.4
CAS number	:	20123-80-2

Sl. No.	Tests	Specifications	Reference
01.	Appearance	White or almost white, hygroscopic powder	EP
02.	Solubility	Very soluble in water, freely soluble in ethanol, very slightly soluble in 2-propanol, practically insoluble in methylene chloride	EP
03.	Identification A. Specific Absorbance B. Test B C. Reaction of calcium	Shall pass the test Shall pass the test Shall pass the test	EP EP EP
04.	Appearance of solution	Clear and colorless	EP
05.	pH	4.5 to 6.0	EP
06.	Hydroquinone	Shall pass the test	EP
07.	Heavy metals	Max. 15 ppm	EP
08.	Iron	Max. 10 ppm	EP
09.	Water	4.0 % to 6.0 %	EP
10.	Assay as C12 H10CaO10S2 (On anhydrous substance)	99.0 % to 102.0 %	EP

Sl. No.	Tests	Specifications	Reference
01.	Description (Appearance)	White or yellowish white powder	In-house
02.	Solubility	Odourless	In-house
03.	Identification A. Calcium B. Gluconic acid & Lactobionic acid(By TLC)	Shall pass the test Shall pass the test	In-house In-house
04.	Clarity of 10% w/v solution in water at 25°C	Shall be clear to nearly clear	In-house
05.	Colour of 10% w/v solution in water at 25°C	Shall be colourless to very slightly yellow in colour.	In-house
06.	pH of the above 10% w/v solution at 25°C	Between 5.4 and 8.0	In-house
07.	Total halides as Chlorides	Max. 500 ppm	In-house
08.	Sulphate	Max. 400 ppm	In-house
09.	Iron	Max. 40 ppm	In-house
10.	Arsenic	Max. 2 ppm	In-house
11.	Heavy metals	Max. 20 ppm	In-house
12.	Calcium content	6.5% ± 0.5%	In-house

Product Name	:	Calcium Lactate Gluconate
Brand Name	:	EUROCAL PLUS
Molecular Formula	:	(Ca5 (C3H5O3) 6. (C6H11O7) 4. 2H2O
Molecular Weight	:	1551.4
CAS number	:	Calcium Lactate: 5743-47-5 Calcium Gluconate: 18016-24-5

Sl. No.	Tests	Specifications	Reference
01.	Appearance	White, free flowing powder	In-house
02.	Odour & taste	Shall pass the test	In-house
03.	Identification	Shall pass the test	In-house
04.	Appearance of 10% w/v solution in water	Clear to nearly clear and colorless to nearly colorless	In-house
05.	Loss on Drying	Max. 10.0 % w/w	In-house
06.	pH (10% solution)	6.0 - 8.0	In-house
07.	Acidity	Not more than 0.45 % as lactic acid	In-house
08.	Chloride	Not more than 500 ppm	In-house
09.	Sulphate	Not more than 500 ppm	In-house
10.	Iron	Not more than 50 ppm	In-house
11.	Arsenic	Not more than 1 ppm	In-house
12.	Lead	Not more than 5 ppm	In-house
13.	Heavy Metal	Not more than 10 ppm	In-house
14.	Volatile fatty acids	Shall pass the test	In-house
15.	Sucrose & Reducing sugars	Shall pass the test	In-house
16.	Magnesium and alkali metals	Not more than 0.5%	In-house
17.	Calcium Content (as is basis)	11.0 % - 12.0 %	In-house
18.	Solubility in water	22 g / 100 ml	In-house
19.	Particle Size Distribution In-house Passing through U.S 80 mesh	More than 90% w/w	In-house
20.	Bulk density (Loose)	300 - 650 Kg / m3	In-house
21.	Total viable aerobic count	Max. 1000cfu / g	In-house
22.	Total fungus	Max. 100cfu / g	In-house
23.	Enterobacteriaceae	To be absent	In-house
24.	E.coli	To be absent	In-house
25.	Salmonella	To be absent	In-house
26.	Staphylococcus aureus	TTo be absent	In-house
27.	Pseudomonas aeruginosa	To be absent	In-house

Sl. No.	Tests	Specifications	Reference
01.	Characters	White to almost white crystalline powder	In-house
02.	Solubility	Hardly soluble in water. Practically insoluble in 96% ethanol and ether.	In-house
03.	Identification : A. IR B. Calcium	Shall pass the test Shall pass the test	In-house In-house
04.	Acidity or Alkalinity test on 1.5g of substance suspended in 30ml of water, stirred for 5 minutes and filtered	10 ml of the filtrate solution should not consume more than 0.25 ml of 0.01M HCl solution (or) 10 ml of filtrate solution should not consume more than 0.5 ml of 0.01N NaOH solution.	In-house
05.	Specific absorbance	A1cm (1.0%) 286 - 306 at 285nm	In-house
06.	Amino acid test on 1g sample	Shall be absent	In-house
07.	Sulphate	Not more than 200ppm.	In-house
08.	Total heavy metals	Not more than 20ppm.	In-house
09.	Assay by Complexometric titration on dried basis	Between 98.0 % - 101.0 %	In-house