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Testing Methods

The testing methods category contains all types of testing-related information such as Products testing, Raw Material testing, Pharmaceuticals ingredients (Active, Excipient) and Packaging material, etc. More data is appended below

 

Benzalkonium Chloride Solution Raw Material Testing

Benzalkonium Chloride Solution Raw Material Testing

Raw Material, Testing Methods
BENZALKONIUM CHLORIDE SOLUTION STANDARD ANALYTICAL PROCEDURE (SAP) OF RAW MATERIAL. Benzalkonium chloride (BKC), a typical quaternary ammonium salt, is often used as an antiseptic. AMENDMENT STATUS Sr.# Date of Amendment Issue Status Page No Page Status Details of change / review 1 2 Written by Checked by Approved by Authorized by   Analyst   Quality Control Manager   Quality Assurance Manager   General Manager Plant Date: Date: Date: Date: 1.0 Purpose 1.1 To ensure the quality of incoming raw material of Benzalkonium Chloride Solution. 2.0 Scope 2.1 It is applicable for the analysis of Benzalkonium Chloride Solution in the quality control department. 3.0 Respon...
Vancomycin Hydrochloride Raw Material Testing Procedure

Vancomycin Hydrochloride Raw Material Testing Procedure

Raw Material, Testing Methods
In this blog post, we are going to share the Vancomycin Hydrochloride Testing Procedure step by step. Vancomycin Hydrochloride is a very common drug, VANCOMYCIN HYDROCHLORIDE Intravenous use for Methycillin resistant staph aureus bloodstream infections.  Now we to our main topic Vancomycin Hydrochloride Testing Procedure Standard Analytical Procedure APPROVAL BLOCK Title Designation Signature/Date Written By: Quality Control Analyst Reviewed By: Quality Control Manager Verified By: Quality Assurance In-charge Approved By: Technical Operation Director Distribution List Sr. # Department New revision # Retrieval Revision # Signature & Date 1 2 DOCUMENT REVISION CONTROL Rev. # Date Init...
How to Test Esomeprazole Magnesium Enteric Coated Pellets

How to Test Esomeprazole Magnesium Enteric Coated Pellets

Raw Material, Testing Methods
In this blog post, we are going to share the Esomeprazole Magnesium Enteric Coated Pellets Testing Procedure step by step for your ease. Esomeprazole is a very common drug for stomach treatment. We have also shared and you can read here the Esomeprazole Magnesium Pellets 22.5 % Raw Material Testing Now we to our main topic Esomeprazole Magnesium Enteric Coated Pellets Testing Procedure Standard Analytical Procedure REFERENCE: USP 44, NF 39 APPROVAL BLOCK Title Designation Signature/Date Written By: Quality Control Analyst Reviewed By: Quality Control Manager Verified By: Quality Assurance In-charge Approved By: Technical Operation Director     Distribution List Sr. # Department New revision # Retrieval Revision ...
Esomeprazole Magnesium Pellets 22.5 % Raw Material Testing

Esomeprazole Magnesium Pellets 22.5 % Raw Material Testing

Raw Material, Testing Methods
Esomeprazole Magnesium Pellets 22.5 % Raw Material Testing RS has been added to the USP Reference Standards section and the table numbers in the test for Organic Impurities have been updated. The Esomeprazole Magnesium Delayed-Release pellets Revision Bulletin supersedes the currently official monograph Esomeprazole Magnesium Pellets 22.5 % Molecular formula: ……………C34H36MgN6O6S2 3H2O Molecular weight: ……………… 767.17   APPROVAL BLOCK Title Designation Signature/Date Written By: Quality Control Analyst Reviewed By: Quality Control Manager Verified By: Quality Assurance In-charge Approved By: Technical Operation Director Distribution List Sr. # Department New revision # Retrieval Revision # Signature & Date 1 ...

Aspirin Raw Material Standard Analytical Procedure

General Topics, Raw Material, Testing Methods
Aspirin Raw Material Standard Analytical Procedure Practical aspects resulting from the implementation of the quality management system in companies in various fields (e.g., information for management of measurement equipment, standard operating procedures or dealing with deviations) allow to obtain a high-quality product. A fundamental role in the proper approach to the requirements imposed on companies in the pharmaceutical industry by the market is their compliance with ISO standards relating to quality management. Aspirin Raw Material Standard Analytical Procedure REFRENCE: BRITISH PHARMACOPOEIA 2020 APPROVAL BLOCK Title Designation Signature/Date Written By: Quality Control Analyst Reviewed By: Quality Control Manager Verified By: Quality Assurance ...
Aripiprazole Raw Material Testing Procedure

Aripiprazole Raw Material Testing Procedure

Testing Methods, Raw Material
The active substance is Aripiprazole, an established active substance described in the European Pharmacopoeia (Ph.Eur.). Aripiprazole is a white or almost white powder and practically insoluble in water. Aripiprazole does not exhibit optical isomerism. The substance shows polymorphism and is manufactured as polymorphic. Aripiprazole Raw Material Testing Procedure is used for both manufacturers of the active substance. The main objective of the ASMF procedure, commonly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property. ARIPIPRAZOLE RAW MATERIAL STANDARD ANALYTICAL PROCEDURE REFRENCE: USP 44, NF 39 APPROVAL BLOCK Title Designation Signature/Date Written By: Quality Control Analyst Reviewed By: Qualit...

Tween 80 (Polysorbate 80) Raw Material Testing

Testing Methods, Raw Material
Introduction STANDARD ANALYTICAL PROCEDURE (SAP) OF RAW MATERIAL TWEEN 80 (POLYSORBATE 80) is a not unusual place nonionic surfactant, emulsifier and solubilizer this is utilized in a huge form of industries and applications. TWEEN 80 (POLYSORBATE 80) is generally utilized in meals products, cosmetics, medications, nutrients and vaccines. There may be many motives a organization may also want to decide the precise quantity of polysorbates of their fabric. For instance, groups may also want to decide a limits of their products, validate analytical techniques for product manufacturing or require the records for opposite engineering purposes. Thus, a well-evolved analytical approach is important for correctly quantitating polysorbates. Due to the chemical shape and chemical houses of TWEEN ...

Xanthan Gum Raw Material SAP

Testing Methods, Raw Material
Xanthan gum is a microbial exo-polysaccharide produced via way of means of Xanthomonas micro organism and it has proper water-solubility, high-quality biocompatibility, intrinsic immunogenic capacity and excessive molecular weight polysaccharide having branched polymeric chains. Such as a excessive diploma of pseudoplasticity, a excessive viscosity even at low concentrations, balance and compatibility with maximum steel salts, high-quality solubility and balance in acidic and alkaline answers and resistance to degradation at accelerated temperatures and diverse pH levels. The xanthan gum become liberated via way of means of FDA (Food and Drug Administration) TABLE OF CONTENTS 1. Purpose 2. Scope 3. Responsibilities 4. Abbreviations 5. Procedure 6. Quality Records 7. Reference ...

Avicel 102 (Microcrystalline Cellulose) Raw Material SAP

Raw Material, Testing Methods
Pharmaceutical excipients Avicel 102 (Microcrystalline Cellulose) Raw Material according to the International Pharmaceutical Excipient Council (IPEC), excipients are the process aids or any substances other than the active pharmaceutical ingredient that are included in pharmaceutical dosage forms. The functionalities of excipient are to impart weight, consistency, and volume which allow accuracy of dose, improve solubility, and in the end increase stability. It can also be proposed to enhance bioavailability, modifying drug release and used in product quick identification, increase patient acceptability, and facilitate dosage form design. Excipients classified as: Primary excipients: diluents (filler), binders (adhesives), disintegrants, lubricants, antiadhesives, glidants.  Complete Te...

Aerosil-200 (Colloidal Anhydrous Silica) Raw Material SAP

Testing Methods, Raw Material
AEROSIL-200 (Colloidal Anhydrous Silica) Raw Material, in Pharma is a high purity amorphous anhydrous colloidal silicon dioxide for use in pharmaceutical products which fulfils the analytical requirements of the currently valid versions of the British Pharmacopeia. It is complete testing according to pharmacopoeia methods.   TABLE OF CONTENTS 1. Purpose 2. Scope 3. Responsibilities 4. Abbreviations 5. Procedure 6. Quality Records 7. Reference 8. List of recipients AMENDMENT STATUS Sr.# Date of Amendment Issue Status Page No Page Status Details of change / review 1 2 Written by Checked by Approved by Authorized by   Analyst   Quality Control Manager   Quality Assurance Manag...