Author: KBS.

Aug152023 by KBS.2 Comments

A simple HPLC method for determination of Tizanidine hydrochloride in pharmaceutical preparations

Throughout both the in-process and finished stages, these analyses help ensure the quality, safety, and efficacy of Tizanidine Hydrochloride Tablets, meeting regulatory requirements and providing reliable treatment for patients. A simple HPLC method for determination of Tizanidine hydrochloride in pharmaceutical preparations It's important to note that specific testing protocols may vary based on regulatory guidelines and the manufacturer's quality control procedures. Analyzing the in-process and finished stages of Tizanidine Hydrochloride Tablets involves evaluating various aspects of the manufacturing process and the final product. Tizanidine Hydrochloride is a medication primarily used to treat muscle spasms and is commonly formulated into tablet dosage forms. Here's an overview of wha...

Jul272023 by KBS.No Comments

Procedure for Analysis at the In-process and Finished Stage of the Mecobalamin 500mcg Tablet

Testing Methods, Product, SOPs

Analyzing Mecobalamin 500mcg tablets at both the in-process and finished stages is essential to ensure the quality, safety, and efficacy of the product. The analysis involves various tests and quality control measures. Below is a general Procedure for Analysis at the In-process and Finished Stage of the Mecobalamin 500mcg Tablet Have the data and results reviewed by authorized personnel, including quality control and quality assurance teams, before approving the product for release or further processing? Always follow approved procedures and protocols specific to your laboratory and adhere to Good Manufacturing Practices (GMP) to ensure the accuracy and reliability of the analysis. This procedure is a general guideline and may need to be adapted based on the specific requirements and...

Jun82023 by KBS.No Comments

SOP for Finished Product Analysis of Misoprostol 200mcg Tablet by HPLC Method

Testing Methods, Product, Quality Control, SOPs

For misoprostol, identification, assay, and related substances were considered essential, given the link to efficacy and the known instability of the product. SOP for Finished Product Analysis of Misoprostol 200mcg Tablet by HPLC Method due to the low ratio of API content to tablet mass and therefore higher risk of non-homogeneity within batches, content uniformity was included. Dissolution or disintegration was not included as misoprostol is a highly soluble substance (19), and anecdotally these parameters are rarely found out of specification (OOS) for misoprostol products. Misoprostol tablets were analyzed for the selected parameters using the methods and specifications described in the International Pharmacopoeia PURPOSE: To describe the procedure for analysis at the in-process and f...

Jun82023 by KBS.No Comments

SOP for Finished Product Analysis of Sertraline Hydrochloride Tablet By UV and HPLC Method

Testing Methods, Product, Quality Control, SOPs

Standard Operating Procedure (SOP) for Finished Product Analysis of Sertraline Hydrochloride by UV and HPLC Method PURPOSE: To describe the procedure for analysis at the in-process and finished stage of the Sertraline Hydrochloride Tablet. SCOPE: This SAP gives a detailed outline for the finished product analysis of the Sertraline Hydrochloride 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 procedures. It is the responsibility of QC Manager to assist and ensure the Testing Procedure as per SAP and to make certain that this SAP is followed in its entirety, reviewed regularly, and revised as necessary. REFERENCE: USP 44, NF ...

Jun52023 by KBS.No Comments

SOP for Finished Product Analysis of Diclofenac sodium 75 mg/Misoprostol 200 mcg By UV and HPLC Method

Testing Methods, Product, Quality Control, SOPs

Diclofenac sodium 75 mg/Misoprostol 200 mcg is a combination medication commonly used for the treatment of arthritis and to prevent ulcers in people who are at risk while taking nonsteroidal anti-inflammatory drugs (NSAIDs). Assay testing for this combination product involves analyzing both diclofenac sodium and misoprostol to ensure their proper quantities and quality in the finished product. SOP for Finished Product Analysis of Diclofenac sodium 75 mg/Misoprostol 200 mcg By UV and HPLC Method ensures that the diclofenac sodium 75 mg/Misoprostol 200 mcg tablets contain the correct amounts of both active ingredients, which is important for their effectiveness and safety. It helps to maintain the quality and efficacy of the medication and ensures compliance with regulatory requirements and...

Jun52023 by KBS.No Comments

Determination of Mirtazapine in Tablets by UV and HPLC Method

Testing Methods, Product, SOPs

Assay testing ensures that the finished Mirtazapine tablets are consistent in their mirtazapine content, which is crucial for their effectiveness and safety. Determination of Mirtazapine in Tablets by UV and HPLC Methods helps maintain the quality and efficacy of the medication and ensures that it meets regulatory requirements and standards. Mirtazapine is an antidepressant medication commonly used to treat major depressive disorder. Assay testing is performed to determine the quantity and quality of the active pharmaceutical ingredient (API) in a finished product, such as Mirtazapine tablets. It ensures that the tablets contain the correct amount of the active ingredient and meets the specified standards. PURPOSE: To describe the procedure for analysis at the in-process and finished st...

Jun12023 by KBS.No Comments

CLOPIDOGREL 75 mg + ASPIRIN 75 mg Tablet Finish Product Testing Procedure

Testing Methods, Product, Quality Control, SOPs

Testing the finished product of Clopidogrel 75 mg + Aspirin 75 mg tablets involves various quality control measures to ensure the safety, efficacy, and consistency of the medication. CLOPIDOGREL 75 mg + ASPIRIN 75 mg Tablet Finish Product Testing Procedure is important to note that this is a general overview of the testing procedure, and specific requirements may vary based on the country, regulatory guidelines, and the particular version of the monograph being followed. Always consult the relevant monographs, guidelines, and validated testing procedures for accurate and reliable testing of Clopidogrel 75 mg + Aspirin 75 mg tablets. Here is a general outline of the testing procedure for Clopidogrel 75 mg + Aspirin 75 mg tablets: PURPOSE: To describe the procedure for analysis at the in...

Jun12023 by KBS.No Comments

Method for Analysis of Ivabradine hydrochloride Tablet with High-Performance Liquid Chromatographic

Testing Methods, Product, Quality Control, SOPs

Testing the finished product of Ivabradine HCl tablets involves various quality control measures to ensure the safety, efficacy, and consistency of the medication. Method for Analysis of Ivabradine hydrochloride Tablet with High-Performance Liquid Chromatographic Here is a general overview of the testing procedure for Ivabradine HCl finished products: Please note that this is a general outline of the testing procedure, and the specific requirements may vary depending on the country, regulatory guidelines, and the particular version of the monograph being followed. Always consult the relevant monographs, guidelines, and validated testing procedures for accurate and reliable testing of Ivabradine HCl finished products. PURPOSE: To describe the procedure for analysis at the in-process and ...

Jun12023 by KBS.No Comments

SOP for Finished Product Analysis of Mirtazapine Tablet By UV and HPLC Method

Testing Methods, Product, Quality Control, SOPs

Testing Mirtazapine tablets should be done by a qualified healthcare professional or a laboratory. They will use specific methods and equipment to ensure the quality, purity, and consistency of the medication. SOP for Finished Product Analysis of Mirtazapine Tablet By UV and HPLC Method However, if you are referring to verifying the authenticity of the tablets. The United States Pharmacopeia (USP) provides standards and guidelines for testing the quality of pharmaceutical products, including Mirtazapine tablets. Here is a general overview of the testing procedures that may be followed according to the USP: PURPOSE: To describe the procedure for analysis at the in-process and finished stage of Mirtazapine Tablet. SCOPE: This SAP gives a detailed outline for the finished product analysi...

May312023 by KBS.No Comments

Development of a Simple HPLC Method for Determination of Azithromycin in Tablet

Testing Methods, Product, Quality Control, SOPs

It is recommended to follow established protocols, official pharmacopoeial methods, and Development of a Simple HPLC Method for the Determination of Azithromycin in Tablets or validated procedures during the development and validation of the HPLC method for the determination of Azithromycin in tablets. PURPOSE: To describe the procedure for analysis at the in-process and finished stage of the Azithromycin Tablet. SCOPE: This SAP gives a detailed outline for the finished product analysis of Azithromycin 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 procedures. It is the responsibility of the QC Manager to assist and ensure t...