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Cefazolin Sodium (Sterile) Testing Procedure

Cefazolin Sodium (Sterile) Testing Procedure

Testing Methods, Raw Material
Cefazolin Sodium (Sterile) Testing Procedure 1.0 PURPOSE This raw material specification and analysis prescribes the requirements for Cefazolin Sodium (Sterile) which is used in Injection. 2.0 SCOPE 2.1 It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. 2.2 Item code 3.0 REFERENCES BP/USP/Inhouse 4.0 DEFINATIONS Follow Sop 5.0 SPECIFICATIONS BP/USP/Inhouse TESTS SPECIFICATIONS 1 Physical: Form Very Hygroscopic Powder 2 Colour: White or almost White 3. Solubility: Freely soluble in water, very slightly soluble in alcohol , practically insoluble in Ether. 4. Specific Optical Rotation: -15° to -24° on dried basis at 20.0°C 5 Reconstitution: 2.1 ml (±0.1 ml) 6 Reconstit...
Water Treatment in Pharmaceuticals Plant SOPs

Water Treatment in Pharmaceuticals Plant SOPs

Production
Water Treatment in Pharmaceuticals Plant is for describe all the procedure of Water Treatement in Pharmaceuticals plants. 1.0 OBJECTIVE 1.1 To describe the procedure for water treatment plant operation. 2.0 SCOPE 2.1 The scope of this SOP pertains to the water treatment plant (Reverse osmosis plant) 3.0 RESPONSIBILITIES 3.1 It is the responsibility of Operator and section Supervisor (tablet and capsule) to follow this SOP as it is written. 3.2 It is the responsibility of Production Pharmacist (Tablet and Capsule) to ensure that this procedure is followed as it is written. 3.3 It is the responsibility of production manager to make certain that this SOP is followed in its entirety, reviewed and updated as necessary. 4.0 DEFINITIONS & ABBREVIATIONS 4.1 SOP: Standard ...

Insect And Rodent Control SOPs

General Topics, Production
To control insects in pharmaceuticals, this SOP is created Insect And Rodent Control SOPs, Insect and rodents are too much harmful in pharmaceuticals unit. 01 PURPOSE This procedure is established for control of insects and rodents in the plant. 02 SCOPE It is applicable in plant. 03 RESPONSIBILITIES A) It is the responsibility of Production Manager, to ensure that this SOP is followed in its entirety, reviewed and update as necessary. 04 PROCEDURE 4.1 Chemicals required for insect control a) Insecticides b) Fumigants a) Insecticides: Insecticides are classified according to the type of action that results in destruction of the insects. Synthetic organic compound, a single material, produces insecticidal action in several ways. Certain materials are selected and used, howev...

Entry and Exit for Workers SOPs

General Topics, Production
Entry and Exit for Workers SOPs are created for the a standard Rules to followed by all the worker of pharmaceuticals factory. 1.0 OBJECTIVE 1.1 To describe the procedure for Plant entry/exit through Workers Entrance. 2.0 SCOPE The scope of this SOP pertains to both male and female workers entry or exit in Plant through Workers Entrance. 3.0 RESPONSIBILITIES 3.1 It is the responsibility of all male and female Workers to follow this SOP during Entry or Exit in Plant through Workers Entrance. 3.2 It is the responsibility of Production Manager, to ensure that this SOP is followed in its entirety, reviewed and update as necessary. 4.0 DEFINITIONS & ABBREVIATIONS 4.1 SOP: Standard Operating Procedure 4.2 QC: Quality Control 4.3 QA: Quality Assurance 5.0 MATERIALS & EQUIPME...
How Can Test Vitamin B6 (Pyridoxine Hydrochloride)

How Can Test Vitamin B6 (Pyridoxine Hydrochloride)

Testing Methods, Raw Material
1.0 PURPOSE This raw material specification & analysis prescribes the requirements for Vitamin-B6 (Pyridoxine) Hydrochloride, which is one of the components use for Syrup, Injection, Tablet and Capsule. 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 USP/BP/Assay of vitamins in Pharmaceutical Preparation 4.0 DEFINITIONS Follow SOP 5.0 SPECIFICATIONS USP/BP/BP/Assay of vitamins in Pharmaceutical Preparation PHYSICAL ANALYSIS 1 Physical: Form Crystalline Powder 2 Colour: White to almost white 3 Melting Point: At about 205° with decomposition 4 Solubility: Freely soluble in water. Sparingly soluble in ethanol 96%. 5 pH: of 10% w/v solution 2.4 t...
Vitamin C (Ascorbic Acid) Testing Procedure

Vitamin C (Ascorbic Acid) Testing Procedure

Raw Material, 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 ...

Clarithromycin (Micronized) Raw Material Testing Procedure

Raw Material, Testing Methods
Clarithromycin (Micronized) Raw Material Testing Procedure specification & analysis prescribes the requirements for Clarithromycin (Micronized), which is one of the components of tablet. It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. 1.0 PURPOSE This raw material specification & analysis prescribes the requirements for Clarithromycin (Micronized), which is one of the components of 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 USP/Inhouse 4.0 DEFINITIONS Follow Company Quality Manual 5.0 SPECIFICATIONS USP/Inhouse TESTS SPECI...
Diclofenac Sodium SR pellets 32% Testing Procedure

Diclofenac Sodium SR pellets 32% Testing Procedure

Testing Methods, Raw Material
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

Dioctahedral Smectite Raw Material Testing Procedure

Testing Methods, Raw Material
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

Levosulpiride Raw Material Testing Procedure

Testing Methods, Raw Material
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...