Pharmaceuticals

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Recently, press releases have questioned the potency as well as the safety of Pharmaceuticals compounded in pharmacies for use in nursing homes and other skilled care facilities. Northeast Laboratories, Inc. is an FDA inspected laboratory that offers a full range of pharmaceutically oriented chemical and microbiological procedures that provide pharmacies with assurances that they need to produce a safe, effective product as well as one that would meet the scrutiny of the Food and Drug Administration.

Chemistry
Stability Studies
Microbiology
Method Development and Validation

The Pharmaceutical Division of Northeast Laboratories was established in 1997. It began servicing a small health care manufacturer and has since grown to service distributors, manufacturers and suppliers as well as small and large chain pharmacies. Following is a partial list of our capabilities. Please contact us to discuss your testing needs.

Chemistry:

Raw Materials
Bulk Products
Final Products
Assays / Active Ingredients
Identifications
Vitamins
Enzyme Assays
Amino Acid Screening
Chromatographic Purity
Volatile Organic Impurities
Optical Density / Specific Rotation
Controlled Substances
Water by Karl Fischer
Contaminants
Content Uniformity
Stability
Tablet Disintegration Testing
Tablet Dissolution Testing
Container and Closure Tests
Method Development
Method Validation
Total Organic Carbon / Water

Microbiology:

Anti-microbial Effectiveness Testing (USP 51)
Microbial Limits (USP 61)
Sterility (USP 71)
Antibiotic Microbial Assay (USP 81)
Bacterial Endotoxins (USP 85)
Bioburden Analysis
Stability Studies
Disinfectant Effectiveness Studies
Fungal Resistance Studies
Particle Size Distribution
Method Development
Water for Pharmaceutical Purposes (USP 1231)
Validation of Microbial Recovery from Pharmacopeia Articles (USP 1227)

Please note: Additional testing available on request.

To view a slideshow demo of how we can help you, click here