Author: KBS.

Mar152023 by KBS.No Comments

SOP for Ondansetron 8mg Tablet Testing by UV HPLC Method

There are different testing methods for Ondansetron tablets, but a common one is the UV HPLC method This method should be performed by trained personnel in a controlled environment, and all necessary safety precautions should be taken. This SOP is intended to provide a standardized method for the testing of Ondansetron 8mg tablets by UV High Performance Liquid Chromatography (HPLC) method. PURPOSE: To describes the procedure for analysis at in-process and finished stage of Ondansetron 8mg Tablet. SCOPE: This SAP gives detailed outline for the finished product analysis of Ondansetron 8mg Tablet and will cover In process testing activities on physical, chemical & instrumental basis. RESPONSIBILITY: QC Analyst is responsible for physical / chemical testing and preparing standard ana...

Mar152023 by KBS.No Comments

SOP for Solifenacin Succinate 5 mg Tablet Testing by UV HPLC Method

Product, General Topics, SOPs, Testing Methods

Solifenacin Succinate 5 mg Tablet is a medication used to treat overactive bladder symptoms, such as urgency, frequency, and incontinence. The testing procedure for this medication involves a combination of preclinical and clinical studies to evaluate its safety, efficacy, and pharmacokinetics. Preclinical studies involve testing the medication in animal models to determine its toxicity, pharmacokinetics, and pharmacodynamics. These SOP for Solifenacin Succinate 5 mg Tablet Testing by UV HPLC Method studies help researchers identify any potential safety concerns and determine appropriate dosages for humans. Clinical studies involve testing the medication in human subjects to evaluate its safety and efficacy. These studies are typically conducted in several phases, starting with small...

Mar152023 by KBS.No Comments

SOP for Metformin Hydrochloride and Sitagliptin Phosphate Tablet Testing by UV and HPLC Method

Product, SOPs, Testing Methods

Sitagliptin + Metformin HCl Tablet is a combination medication used to treat type 2 diabetes. Testing for this medication typically involves a combination of preclinical and clinical studies to evaluate its safety, efficacy, and pharmacokinetics. Preclinical studies involve testing the medication in animal models to determine its toxicity, pharmacokinetics, and pharmacodynamics. These studies help researchers identify any potential safety concerns and determine appropriate dosages for humans' SOP for Metformin Hydrochloride and Sitagliptin Phosphate Tablet Testing by UV and HPLC Method. Clinical studies involve testing the medication in human subjects to evaluate its safety and efficacy. These studies are typically conducted in several phases, starting with small studies on unhealthy...

Mar62023 by KBS.No Comments

SOP for Preparation of Batch Manufacturing Record (BMR)

Quality Assurance, General Topics, SOPs

A batch Manufacturing Record (BMR) is a document that contains all the necessary information related to the manufacturing process of a specific batch of a product. The SOP for Preparation of Batch Manufacturing Record (BMR) is a critical document that provides a comprehensive and detailed account of the manufacturing process and is used to ensure that the batch is manufactured in accordance with established procedures and specifications. Overall, the BMR should be a complete and accurate record of the manufacturing process for a specific batch of a product. It should provide all the information necessary to ensure that the batch is manufactured in accordance with established procedures and meets the required quality standards. PURPOSE The purpose of this SOP is to set forth the procedure...

Mar32023 by KBS.No Comments

SOP for Receipt & Storage of Materials in Pharmaceuticals

General Topics

The responsibility for the proper receipt, storage, and tracking of materials lies with all personnel involved in the process, including but not limited to procurement staff, warehouse staff, and inventory management staff. The SOP for Receipt & Storage of Materials in Pharmaceuticals ultimate accountability for compliance with this SOP rests with the management of the organization. All personnel involved in the receipt, storage, and tracking of materials must be trained on this SOP and must adhere to its provisions. Any updates to this SOP must be communicated to all relevant personnel and training must be provided accordingly. PURPOSE: To lay down a procedure for receiving the raw materials and packaging materials. SCOPE: This SOP is applicable for receipt of Raw and Packing mate...

Mar32023 by KBS.No Comments

SOP for Diclofenac Sodium SR 100mg Tablet Tested UV and HPLC Methods

Testing Methods, General Topics, Product, SOPs

SOP for Diclofenac Sodium SR 100mg Tablet Tested UV and HPLC Methods to determine its purity and quality. Both UV and HPLC methods are widely used in pharmaceutical laboratories to test the quality and purity of diclofenac sodium tablets. These methods are highly accurate and reliable and are used to ensure that the tablets meet the required quality standards. PURPOSE: To describe the procedure for analysis at in-process and finished stage of Diclofenac Sodium SR 100mg Tablet. SCOPE: This SAP gives a detailed outline for the finished product analysis of Diclofenac Sodium SR 100mg Tablet and will cover In process testing activities on a physical, chemical & instrumental basis. RESPONSIBILITY: QC Analyst is responsible for physical / chemical testing and preparing standard analytic...

Mar32023 by KBS.No Comments

SOP for Vonoprazan 10 mg Tablet Testing Procedure

Testing Methods, General Topics, Product, SOPs

Vonoprazan Fumarate is a medication used to treat gastroesophageal reflux disease (GERD) and other gastrointestinal disorders. The SOP for Vonoprazan 10 mg Tablet Testing Procedure should follow the appropriate regulatory guidelines and be validated to ensure the accuracy, precision, and reliability of the results. PURPOSE: To describe the procedure for analysis at in-process and finished stage of Vonoprazan 10 mg Tablet. SCOPE: This SAP gives a detailed outline for the finished product analysis of Vonoprazan 10 mg Tablet and will cover In process testing activities on a physical, chemical & instrumental basis. RESPONSIBILITY: QC Analyst is responsible for physical / chemical testing and preparing standard analytical procedure. It is the responsibility of QC Manager to assist an...

Mar22023 by KBS.No Comments

Trimetazidine Hydrochloride MR 35mg Tablet Testing Procedure SOP

Testing Methods, General Topics, Product, SOPs

Trimetazidine Hydrochloride MR 35 mg Tablet assay testing is a process to determine the potency of the active ingredient in the medication. This Trimetazidine Hydrochloride MR 35mg Tablet Testing Procedure SOP ensures that the medication contains the correct amount of the active ingredient, trimetazidine hydrochloride, which is necessary for it to be effective. PURPOSE: To describe the procedure for analysis at in-process and finished stage of Trimetazidine Hydrochloride MR 35 mg Tablet. SCOPE: This SAP gives a detailed outline for the finished product analysis of Trimetazidine Hydrochloride MR 35 mg Tablet and will cover In process testing activities on a physical, chemical & instrumental basis. RESPONSIBILITY: QC Analyst is responsible for physical / chemical testing and prepar...

Mar22023 by KBS.No Comments

SOP for Testing Itopride 50mg Tablet by UV spectroscopy

Testing Methods, General Topics, Product, SOPs

UV (Ultraviolet) testing is a commonly used technique in the pharmaceutical industry to determine the purity and concentration of a drug substance or a drug product. SOP for Testing Itopride 50mg Tablet by UV spectroscopy is based on the measurement of the absorption of UV light by a compound in a solution. PURPOSE: To describe the procedure for analysis at in-process and finished stage of Itopride 50 mg Tablet. SCOPE: This SAP gives a detailed outline for the finished product analysis of Itopride 50 mg Tablet and will cover In process testing activities on a physical, chemical & instrumental basis. RESPONSIBILITY: QC Analyst is responsible for physical / chemical testing and preparing standard analytical procedure. It is the responsibility of QC Manager to assist and ensure Tes...

Feb272023 by KBS.No Comments

SOP for Amlodipine 5mg/Valsartan 160mg/Hydrochlorothiazide 12.5mg Tablet Assay Testing

Testing Methods, General Topics, Product, SOPs

It is important to follow appropriate safety precautions when handling these drugs and to adhere to the manufacturer's instructions for the assay procedure of SOP for Amlodipine 5mg/Valsartan 160mg/Hydrochlorothiazide 12.5mg Tablet Assay Testing. PURPOSE: To describe the procedure for analysis at the in-process and finished stage of SOP for Amlodipine 5mg/Valsartan 160mg/Hydrochlorothiazide 12.5mg Tablet Assay Testing. SCOPE: This SAP gives a detailed outline for the finished product analysis of SOP for Amlodipine 5mg/Valsartan 160mg/Hydrochlorothiazide 12.5mg Tablet Assay Testing and will cover In process testing activities on physical, chemical & instrumental basis. RESPONSIBILITY: QC Analyst is responsible for physical / chemical testing and preparing standard analytical proce...