Testing Methods

Feb92022 by KBS.No Comments

Determination of Chlorpheniramine Maleate Raw Material

Chlorpheniramine Maleate Testing Procedures and specification & analysis prescribes the requirements for Determination of Chlorpheniramine Maleate Raw Material, which is one of the components Alternate Method of Analysis on UV System and Other Testing procedures. 1.0 PURPOSE This raw material specification & analysis prescribes the requirements for Chlorpheniramine Maleate, which is one of the components Syrup and 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/BP/BP/Inhouse 4.0 DEFINITIONS Follow the SOPs 5.0 SPECIFICATIONS USP/BP/BP/Inhouse PHYSICAL ANALYSIS Physical Form Crystalline Powder Colour White Odour...

Feb92022 by KBS.No Comments

How To Test Cephradine L-Arginine Raw Material

Testing Methods, Raw Material

How To Test Cephradine L-Arginine Raw Material specification & analysis prescribes the requirements with IR spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. How To Test Cephradine L-Arginine Raw Material PURPOSE This raw material specification & analysis prescribes the requirements for How To Test Cephradine L-Arginine Raw Material (Sterile) which is used in Injection. SCOPE How To Test Cephradine L-Arginine Raw Material is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. REFERENCES USP/BP/Inhouse/ACS DOBFAR s.p.a of How To Test Cephradine L-Arginine Raw Material. DEFINITIONS Follow How To Test Cephradine L-Arginine Raw Mate...

Feb82022 by KBS.No Comments

Celecoxib Raw Material Testing

Testing Methods, Raw Material

Celecoxib Raw Material Testing. In this post, we share Celecoxib Raw Material Testing. You may also check our other Testing procedures here. 1.0 PURPOSE This raw material specification and analysis prescribes the requirements for Celecoxib, which is one of the components of Capsule. 2.0 SCOPE 2.1 It is applicable in Materials, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. 3.0 REFERENCES Martindale / Manufacturer Specification 4.0 DEFINATIONS Company Quality Manual 5.0 SPECIFICATIONS Manufacturer Specification PHYSICAL ANALYSIS 1 Physical Form Fine powder 2 Colour White to Off-White 3 Solubility Soluble in Methanol 4 Melting Point 158°C to 162°C 5 Loss on Drying Note more than 0.5 % CHEMICAL ANALYS...

Feb42022 by KBS.No Comments

Cefuroxime Axetil Raw Material Testing Procedure

Testing Methods, Raw Material

As we know Cefuroxime is used to treat a variety of bacterial infections. This drug is known as a cephalosporin antibiotic. It works by stopping the growth of bacteria. This antibiotic only treats bacterial infections. It does not work for viral infections (like cold, flu). In this post, we are going to share Cefuroxime Axetil Raw Material Testing Procedure. You may also check our other Testing procedures here Here is the complete process of Cefuroxime Axetil Raw Material Testing with steps 1.0 PURPOSE It is established to describe the specification and analysis of Cefuroxime Axetil Crystalline Special, which is one of the components of Suspension. 2.0 SCOPE It is applicable in the Materials, Product Development and Quality Assurance Department to confirm its physical and chemical ...

Feb42022 by KBS.No Comments

Ceftriaxone Sodium Sterile Raw Material Testing

Raw Material, Testing Methods

Ceftriaxone Sodium Sterile Raw Material Testing 1.0 PURPOSE This raw material specification and analysis prescribes the requirements for Ceftriaxone Sodium Sterile, which is one of the components of Injection. 2.0 SCOPE 2.1 It is applicable in materials, Product Development and Quality Assurance Department to confirm its Physical and Chemical specifications. 2.2 Item Code No..... 3.0 REFERENCES BP/USP/Martindale 31st Edition /Merck Index 12th Edition/ In-house 4.0 DEFINITIONS Company Quality Manual 5.0 SPECIFICATIONS Reference Martindale 31st Edition /USP/ Merck Index/ In-house Specifications. TESTS AND SPECIFICATIONS PHYSICAL ANALYSIS 1. Physical: Form Crystalline Powder 2. Colour: Almost white to yellowish 3. Color after reconstitution: Light yellow 4. Reconst...

Feb32022 by KBS.No Comments

How to Test Cefotaxime Sodium

Testing Methods, Raw Material

Testing Procedure Cefotaxime Sodium 1.0 PURPOSE This raw material specification and analysis prescribes the requirements for Cefotaxime Sodium (Sterile) which is used in Injection. 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/USP 4.0 DEFINITIONS Follow Sop 5.0 SPECIFICATIONS USP/BP/USP PHYSICAL ANALYSIS 1 Physical Form Fine Powder 2 Colour Off White 3 Reconstitution Time Not more than 1 minute 5 pH After Reconstitution 4.5 to 6.5 at 25°C +- 2° 6 Moisture Contents Not more than 5% 7 Reconstitution 2.1 ml +- 0.1 ml 8 Clarity Clear without any visible contamination CHEMICAL ANALYSIS 9 Identification of Cefotaxime Sodium examinat...

Feb32022 by KBS.No Comments

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...

Jan312022 by KBS.No Comments

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...

Jan312022 by KBS.No Comments

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 ...

Jan292022 by KBS.No Comments

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...