Testing Methods

1.0 PURPOSE This Raw material Specification & Analysis prescribes the requirements for Vitamin-C (Ascorbic Acid) coated which is one of the components of Multivitamin Tablet. 2.0 SCOPE It is applicable in Material, Product Development and Quality Assurance Department to confirm its physical & chemical specifications. 3.0 REFERENCE BP/USP/In house 4.0 DEFINITIONS Follow SOP 5.0 SPECIFICATIONS BP/USP/In house PHYSICAL ANALYSIS Physical Form: Crystalline Powder or colorless crystals Colour: White or almost white Odour: Odourless or Almost Odourless Solubility: Freely soluble in water and soluble in ethanol (96%) and insoluble in chloroform. pH: 2.1 to 2.6 at 20°C to 25°C Melting point: About 190°C with decomposition. Bulk Density: Should be ...

Diclofenac Sodium SR pellets 32% STANDARD ANALYTICAL PROCEDURE METHOD OF ANALYSIS 1.Description: Take about 1.0 g of pellets and transfer into suitable clean and dry petri dish spread as evenly in the dish and observe the physical appearance of the pellets. It should be white to off-white in Colour and spherical shaped. 2.Identification By: UV-Spectrophotometer The chromatogram obtained by sample preparation corresponds to that of the standard preparation, as obtained in the assay. 3.Loss on Drying: Take about 1.0 g of the sample and crush it into the powder and determine its loss on drying with the help of LOD apparatus. It should not more than 5.0%. 4.Sugar Test: Crush the pellets to powder. Weigh 1gm of sample and transfer it to a beaker. Add 20ml of water and stir it...

Dioctahedral Smectite Raw Material Testing Procedure or Standard Analytical Procedure of Dioctahedral Smectite Appearance: It should be off- white powder. pH : Take 1.0g sample; add 50ml water to make a suspension. Shake 5 minutes and stand for 1 hour. Take upper clear water to check pH. Loss on drying : Take 2.0 g sample to be examined, dry at 105℃ to constant weight, the result should not exceed 10.0 %( according to CP2005 Volume II appendix VIII L). Carbonate: Take 0.2g sample to a test tube; add 2ml water to make a suspension. Add 2ml acetic acid solution (2mol/l) and quickly block it with a plug, which have a bent glass tube in the center. Heat the suspension slowly; collect the escaping gas to calcium hydroxide solution, no white precipitate generated. Chloride: T...

Levosulpiride Raw Material Testing Procedure Description (Specification: White to off white powder) Procedure Spread approximately 2.0 gm of the sample over the cleaned and dried petri dish and examine visually against white background. Check the appearance of colour, nature and any visible foreign particles. Solubility (Specification: Freely soluble in dimethylformamide, sparingly soluble in methanol and slightly soluble in alcohol and in Methylene chloride). Procedure: Weigh the sample in specified quantity and transfer into a test tube. Add specified volume of the solvent shake for few minutes. Observe and record its solubility. Identification A) By Melting Range: Between 182°C to 186°C. Procedure: Crush the substance to very fine powder charge a capillary g...

Cyclobenzaprine HCl SR Pellets Testing Procedure Description: Take about 1.0 g of pellets and transfer it to a clean and dry petridish spread evenly in the dish and observe the physical a appearance of the pellets. It should be pale yellow to creamy colored. Identification By: HPLC The retention time of the major peak in the chromatogram of the sample preparation corresponds to that of the standard preparation, as obtained in the assay. Identification By: UV-Spectrophotometer The spectrum obtained by sample preparation corresponds to that of the standard preparation, as obtained in the assay. Loss on Drying Take about 1.0 g of the sample and crush it into the powder and determine its loss on drying with the help of LOD apparatus. It should not more than 5.0%. S...

Atorvastatin Calcium Raw Material Testing Procedure is taken as a raw material, and the product refined by a mixed solvent is crystallized to obtain high-purity atorvastatin calcium trihydrate. The preparation method provided by the invention is suitable for industrial production. PURPOSE This raw material specification and analysis prescribes the requirements for Atorvastatin Calcium, which is one of the components of “Atorvastatin Calcium” tablet. 2.0 SCOPE It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. 3.0 REFERENCES Merck Index/ Martindale/ Manufacturer specification /In-House Specification 4.0 DEFINATIONS Company Quality Manual 5.0 SPECIFICATIONS Reference Manufactu...

Testing Procedure HPLC method is described for the determination of cinitapride hydrogen tartrate. A drug was subjected to all stress conditions such as preparation reduction, oxidation acidic and alkaline medium. Chromatography, Standard stock solution preparation, Standard solution preparation, Test Preparation, Preparation of Diluent, Preparation of Buffer Preparation of Mobile Phase was recorded on an column using mixture of acetonitrile and phosphate buffer. Description: Take about 2.0 g of the test sample in a watch glass and observe visually over a black back ground. Requirement: It should be a yellow crystalline powder. Solubility: Weigh about 0.1 g of the test sample and transfer into a clean and dry stoppered test tube . Add 10 mL of water and mix the contents . R...