General Topics - Pharma Egg

Oct252023 by KBS.No Comments

Bacterial Endotoxins Test LAL Test (End Point Chromogenic Method)

Microbiology, General Topics, SOPs, Testing Methods

It's important to note that the Bacterial Endotoxins Test LAL Test (End Point Chromogenic Method), is highly sensitive and specific. It's crucial to follow proper protocols and standards to ensure accurate and reliable results, especially in industries where product safety is paramount. The Limulus Amebocyte Lysate (LAL) test is a widely used method for detecting bacterial endotoxins. Endotoxins are heat-stable toxins present in the outer membrane of Gram-negative bacteria. These toxins can cause severe reactions in humans and animals, so it's crucial to detect and quantify their presence, especially in medical devices and pharmaceutical products. The LAL test operates on the principle that the LAL enzyme in the horseshoe crab's blood reacts with bacterial endotoxins, leading to a ge...

Oct162023 by KBS.No Comments

Determination of lornoxicam in pharmaceutical preparations by UV and HPLC spectrophotometric methods

General Topics

The testing procedures for pharmaceutical products like Lornoxicam 8mg Tablets typically involve a series of rigorous steps to ensure the safety, efficacy, and quality of the medication. These procedures are conducted during the development, manufacturing, and quality control phases. Determination of lornoxicam in pharmaceutical preparations by UV and HPLC spectrophotometric methods Before the tablet is manufactured, researchers and pharmaceutical companies work on developing the appropriate formulation. This includes determining the active ingredient (Lornoxicam, in this case) and other excipients (inactive ingredients) that will make up the tablet. PURPOSE: To describe the procedure for analysis at the in-process and finished stage of Lornoxicam 8mg Tablet. SCOPE: This SAP gives a...

Aug152023 by KBS.2 Comments

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

General Topics

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...

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...

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 XhaamiNo Comments

Relative Humidity vs Absolute humidity vs Specific humidity

SOPs, General Topics, Production, Quality Assurance

Relative humidity, absolute humidity, and specific humidity are three important atmospheric parameters that describe the amount of moisture in the air. Relative Humidity vs Absolute humidity vs Specific humidity Although all three are related to the moisture content of air, they each measure different aspects of it. Relative humidity refers to the amount of water vapor in the air compared to the amount of water vapor the air can hold at a given temperature. It is expressed as a percentage, with 100% relative humidity meaning that the air is saturated and can no longer hold any additional moisture. Absolute humidity refers to the actual amount of water vapor present in the air, measured in units such as grams per cubic meter (g/m3) or grains per cubic foot (gr/ft3). Absolute humidity ...

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...