Overview:
Residual solvents are organic volatile chemicals used or produced during the manufacturing of drug substances or excipients. The Assay of Residual Solvents ensures that these compounds are within acceptable safety limits, as outlined by international pharmacopoeias.

Test Description:
Samples of drug products or raw materials are prepared and subjected to analytical techniques to detect, quantify, and classify residual solvents. This is a critical quality control step for patient safety, regulatory compliance, and process validation.

Purpose & Benefits:

• Identify and quantify Class 1 (toxic), Class 2 (limited), and Class 3 (low toxic potential) solvents
• Verify that residual solvent levels do not exceed permissible limits
• Meet regulatory requirements for drug product registration and batch release
• Ensure consumer safety and product quality

Industries Served:

• Pharmaceutical & Biopharma Manufacturers
• Active Pharmaceutical Ingredient (API) Producers
• Nutraceuticals, Herbal Extracts, and Fine Chemicals
• Cosmetic and Medical Device Manufacturers

Microbial Testing – Ensuring Product Sterility & Safety

Overview:
Microbial Testing is essential for verifying the microbiological safety of pharmaceutical, biotechnological, and medical products. This testing ensures that products are free from harmful microorganisms, meet regulatory standards, and are safe for human use.

Test Description:
Depending on the product and its intended use, microbial testing can include:

• Sterility Testing – Confirms the absence of viable microorganisms.
• Bioburden Testing – Determines the number of viable microorganisms prior to sterilization.
• Bacterial Endotoxin (LAL) Testing – Detects the presence of pyrogenic endotoxins from Gram-negative bacteria.

Purpose & Benefits:

• Validate product sterility for parenteral, ophthalmic, and implantable products
• Detect microbial load in raw materials and intermediates
• Ensure product meets Good Manufacturing Practice (GMP) standards
• Protect patient health by preventing microbial contamination

Industries Served:

• Pharmaceuticals & Biopharmaceuticals
• Medical Devices
• Nutraceuticals
• Cosmetics & Personal Care Products
• Healthcare Packaging