Micro-Chem Laboratories

Micro-Chem Laboratories is an independent testing laboratory staffed by dedicated professionals. We offer wide variety of services including Chemical, Microbiological Analysis and Product Development services to the following industries.

Pharmaceuticals - Rx and OTC
Nutritional supplements
Cosmetics
Medical devices

We pride ourselves in providing fast, accurate results to our customers. We maintain a direct line of communication between our clients and our staff to ensure that all testing is performed in accordance with the client's needs and specification.

Micro-Chem operates in compliance with the current Good Manufacturing Practices (cGMPs) as set forth in 21 CFR Parts 210-211. Micro-Chem is registered with the Food Drug Administration (FDA) and the Drug Enforcement Agency (DEA) for testing controlled drug substances (schedules I to V).

Chemical and Microbiological Analytical Capabilities

• Product Specific Method Development, Method Validation, as well as compendial procedures in accordance with USP, NF, BP, and European Pharmacopoeias.
• Chemical Analysis utilizing HPLC, GC with Head Space, FT-IR, Atomic Absorption, Disintegration & Dissolution studies of immediate and sustained release tablets
• Set up Stability Programs for bulk drugs and dosage forms. The products will be placed in Accelerated and Room Temperature stability conditions (as per ICH guidelines) and tested at schedules intervals, as outlined in the Stability protocol.
• Microbial limit tests, Preservative Challenge tests, Total Plate counts, and Water testing. Automated microbiological testing for Salmonella, Listeria etc. using VIDAS.

Micro-Chem is housed in a over 5000 square feet, state of the art facility, in the Branchburg Industrial Park located in New Jersey. The facility consists of adequate and efficiently designed laboratory, equipped with modern equipment. Data integrity, Compliance and Confidentiality constitute the core of our belief.

Micro-Chem has an open door policy for clients and encourages clients to independently audit the facility and review testing procedures with our staff members. We maintain strict client confidentiality. We always strive to deliver reliable results in the shortest possible turnaround time at a reasonable cost.

Analytical Services

• USP/NF and Compendial Analysis of Raw Materials, In-Process and Finished Products.
• Impurity Analyses.
• Analytical Method Development, Methods Improvement and Validation.
• Stability-indicating Assay Development & Validation.
• Develop Stability program and perform Stability testing.
• Dissolution Testing of Immediate and Controlled Release Products.
• Method development for Cleaning and Cleaning Validation

Our Commitment is to contribute to your Growth & Success in a meaningful way.

Product Chemistry

Analytical Capabilities

• HPLC with PDA, UV-Vis, RI
• Automated GC and Head Space GC
• Tablet Dissolution (IR, SR) & Disintegration Studies
• OVI, Trace Heavy Metals
• Analysis of Controlled Drug Substances (schedules I to V)

Spectral Characterization

• Ultraviolet-visible spectrum
• FT-Infrared Spectrum
• Atomic Absorption Spectrum

Laboratory Consulting Services

Conduct laboratory audit for efficiency and compliance to cGMP

Microbiological Services

• Testing per USP, BP, EP and CFR
• Microbial Limit Test / Bio-burden
• Antimicrobial Preservative Effectiveness Test
• Water testing - Total Microbial counts, Presence / Absence for E.coli / Coliforms
• On site Inspections and Microbiological Audits
• Automated testing for Salmonella, Listeria using VIDAS

Product Development

• SR, IR Product Formulation
• Reverse Engineering Product Formulation

Why Micro-Chem?

Micro-Chem has high standards of Quality Assurance to ensure accuracy of data. We follow scientifically sound test methods from USP-NF, AOAC, or develop in-house test methods, which are as good as or better than USP. We adhere to our in-house SOPs that are in accordance with the industry's current Good Manufacturing Practices (cGMPs) We have a rapid turn around time to meet the client's demands at competitive pricing. Our efficient and effective services will meet all your testing needs without costly addition to your staff.

Some of our Esteemed Scientists include:

• Banu Ramachandran, Ph.D.
• Jay Tatake, Ph.D.
• Arun Kulkarni, M. Pharm, MS, MBA
• Carl Rehm, Ph.D
• Pramod Chemburkar, Ph.D

Micro-Chem has a group of highly educated professionals in Chemistry, Microbiology, and Pharmaceutical Sciences with several years of analytical experience. From raw materials, components, in-process materials to finished products, Micro-Chem's full range of analytical services can meet all your testing needs. We can be an extension of your lab for USP-NF, Dissolution, Wet Chemistry, Method Development, Stability Studies, Product evaluation and Consulting Services for your Regulatory and Analytical needs.

Please contact : Arun D. Kulkarni , (908) 231 6691

We deliver Quality Analytical Service in a Cost Effective Way