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Raw Material

In this category, you can get the easiest and time-saving testing methods of Active Pharmaceuticals Ingredients (API) and Excipient Raw Material.

How to Test Xanthan Gum Raw Material

How to Test Xanthan Gum Raw Material

Raw Material, Quality Control, SOPs
It is important to How to Test Xanthan Gum Raw Materials to follow industry standards, such as those set by the American Oil Chemists' Society (AOCS), when testing xanthan gum. Xanthan Gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with Xanthomonas campestris, then purified by recovery with Isopropyl Alcohol, dried, and milled. How to Test Xanthan Gum Raw Material contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid, and is prepared as sodium, potassium, or calcium salt. It yields NLT 4.2% and NMT 5.0% of carbon dioxide, calculated on the dried basis, corresponding to NLT 91.0% and NMT 108.0% of Xanthan Gum. Purpose To ensure the quality of incoming raw material of Xanthan Gum. Scope It ...
How to Test Molnupiravir (Method of Analysis)

How to Test Molnupiravir (Method of Analysis)

Testing Methods, General Topics, Quality Control, Raw Material, SOPs
The testing of Molnupiravir raw material can be done through various methods, How to Test Molnupiravir (Method of Analysis) including High-Performance Liquid Chromatography (HPLC): This method is used to determine the purity and potency of the raw material, Nuclear Magnetic Resonance (NMR) Spectroscopy: This method is used to identify the structure of the raw material, Infrared Spectroscopy (IR): This method is used to identify functional groups in the raw material, Mass Spectrometry (MS): This method is used to determine the molecular weight of the raw material, X-Ray Crystallography: This method is used to determine the crystal structure of the raw material. It is important to follow good manufacturing practices (GMP) and standard operating procedures (SOPs) during the testing process...
How to Test Tapentadol Hydrochloride

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...
SOP for Sampling and Testing of Raw Materials

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 ...
Montelukast Sodium Testing Procedure

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...
How To Test Naproxen Sodium Raw Material

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...
Paracetamol Raw Material Testing By UV Method

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...
Ranitidine HCl Testing UV and HPLC Method

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...
Dextromethorphan Hydrobromide Raw Material Testing

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...
Deionized Water Testing Procedure

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 ...