Raw Material - Pharma Egg

Feb62023 by KBS.No Comments

How to Test Tapentadol Hydrochloride

Testing Methods, Quality Control, Raw Material, SOPs

Tapentadol, a centrally acting opioid analgesic, is used in the treatment of moderate to severe acute and chronic pain, as well as the management of neuropathic pain associated with diabetic peripheral neuropathy in adults (extended release formulation only). How to Test Tapentadol Hydrochloride Tapentadol functions as an opiate agonist by binding to mu-opioid receptors and inhibiting norepinephrine reuptake. Approximately 97% of the parent drug is metabolised. The main route of tapentadol metabolism is conjugation with glucuronic acid to produce glucuronides. Tapentadol and its metabolites (N-desmethyltapentadol and hydroxyl-tapentadol) are excreted almost entirely through the kidneys, with the conjugated form accounting for approximately 70% of the drug excreted in urine. Tapentadol meta...

Jan312023 by KBS.No Comments

SOP for Sampling and Testing of Raw Materials

Raw Material, Quality Control, SOPs

The choice of a SOP for Sampling and Testing of Raw Materials plan should always take into consideration the specific objectives of the sampling and the risks and consequences associated with inherent decision errors. The bibliography at the end of this Annex should be consulted when justifying a sampling plan for a given purpose. All SOP for Sampling and Testing of Raw Materials operations related to sampling should be performed with care, using proper equipment and tools. Any contamination of the sample by dust or other foreign material is liable to jeopardize the validity of the subsequent analyses. Purpose:- It is established to provide the guidelines for the SOP for Sampling and Testing of Raw Materials of sterile & non sterile Raw Materials so as to get the representative ...

Mar52022 by KBS.No Comments

Montelukast Sodium Testing Procedure

Testing Methods, Raw Material, SOPs

Montelukast Sodium Testing Procedure and Raw Material specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Characters Spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, it should be white crystalline powder and determination. Solubility (i) Take approximately 0.5 gram of sample into a clean test tube containing water. Close the test tube with stopper and shake well. The sample slightly soluble in water. (ii) Take approximately 0.5 gram of sample into a clean test tube containing alcohol. Close the test tube with stopper and shake well. The sample slightly soluble in alcohol. (iii) Take approximately 0.5 gram of sample into a clean tes...

Mar52022 by KBS.No Comments

How To Test Naproxen Sodium Raw Material

Testing Methods, Raw Material, SOPs

How To Test Naproxen Sodium Raw Material specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Characters How To Test Naproxen Sodium Raw Material Spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, it should be white to creamy crystalline powder Solubility Soluble in water and in methanol; sparingly soluble in alcohol; very slightly soluble in acetone; and practically insoluble in chloroform and in toluene. Melting point Melts at about 225 °C with determination decomposition Procedure: Grind the Naproxen Sodium sample into a fine powder in a mortar and pack the capillary tube with sample by tapping on a hard surface so as to form a...

Mar52022 by KBS.No Comments

Paracetamol Raw Material Testing By UV Method

Testing Methods, Raw Material, SOPs

Paracetamol Raw Material Testing By UV Method specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Paracetamol Raw Material Testing By UV and Purpose This raw material specification & analysis prescribes the requirements for Paracetamol raw material Testing UV and HPLC Method. Characters Spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, determination it should be white, crystalline powder. Solubility Sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride. Identification Melting point:- 168 °C to 172 °C Procedure: Paracetamol Raw Material Testing By UV Method, Grind the Paracetamol s...

Mar52022 by KBS.No Comments

Ranitidine HCl Testing UV and HPLC Method

Testing Methods, Raw Material, SOPs

Ranitidine HCl Testing UV and HPLC Method Raw Material specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures. Ranitidine HCl Testing UV and HPLC Method and Purpose This raw material specification & analysis prescribes the requirements for Ranitidine HCl raw material Testing UV and HPLC Method. Characters Ranitidine HCl Testing UV and HPLC Method is spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, it should be white to pale yellow, crystalline, practically odorless powder. Is sensitive to light and moisture. Melts at about 140º, with decomposition. Solubility Ranitidine HCl Very soluble in water; sparingly soluble in alcohol. Melt...

Feb252022 by KBS.No Comments

Dextromethorphan Hydrobromide Raw Material Testing

Testing Methods, Raw Material

Dextromethorphan Hydrobromide Raw Material Testing specification & analysis prescribes the requirements with IR spectrum and Alternate Method of Analysis on UV System and Other Testing procedures. Dextromethorphan Hydrobromide Raw Material Testing PURPOSE This raw material specification & analysis prescribes the requirements Dextromethorphan Hydrobromide Raw Material Testing which is used in Syrup & Tablet. 1.0 PURPOSE This raw material specification & analysis prescribes the requirements for Dextromethorphan Hydrobromide which is one of the components of Syrup & 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 4.0 DE...

Feb252022 by KBS.No Comments

Deionized Water Testing Procedure

Testing Methods, Raw Material

Deionized Water Testing Procedure Raw Material specification & analysis prescribes the requirements with and Other Testing procedures. Deionized Water Testing Procedure for Raw Material PURPOSE Deionized Water Testing Procedure PURPOSE This raw material specification & analysis prescribes the requirements for De-ionized water, which is used in different pharmaceutical preparations. SCOPE It is applicable for the analysis of Do-ionized water manufactured in water treatment section. REFERENCES In-house DEFINITIONS Follow SOP determination Pharmaegg.com SPECIFICATIONS In-house PHYSICAL ANALYSIS TESTS SPECIFICATIONS 1. Physical Form Liquid 2. Colour Colourless 3. pH Between 5.0 to 7.0 at 30°C 4. Conductivity Should not be more than 1.4µS/cm at 30°C CHEMICAL ANALYSIS ...

Feb252022 by KBS.No Comments

How to Test Cloxacillin Sodium

General Topics, Raw Material, Testing Methods

How To Test Cloxacillin Sodium 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 Cloxacillin Sodium Raw Material PURPOSE This raw material specification & analysis prescribes the requirements for How To Test Cloxacillin Sodium Raw Material which is used in Capsules. PURPOSE This raw material specification & analysis prescribes the requirements for Cloxacillin Sodium (Compacted) which is one of the component of Capsule. SCOPE It is applicable in Material Department, Product Development and Quality Assurance Department to confirm its physical and chemical specifications. REFERENCES USP/BP/Inhouse DEFINITIONS Follow SOP pharmaegg.co...

Feb92022 by KBS.No Comments

Determination of Chlorpheniramine Maleate Raw Material

Testing Methods, 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...