Quality Assurance Solutions

1. Elemental Impurities Emerge As New Compliance Challenge
   1/22/2019

   After almost 20 years, FDA issued new guidelines in 2018 for elemental impurities. Despite advanced notice, capacity and capabilities remain limited.

2. Cleaning Validation (21 CFR Part 211.67)
   12/5/2008
   Alconox, Inc. can assist you in selecting an appropriate cleaner for cleaning pharmaceutical manufacturing equipment and utensils to prevent malfunctions or contamination that would alter the safety, identity, strength, quality or purity of the drug product beyond the official or other established requirements.
3. Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer
   6/6/2019

   Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer, benchtop design, serial# 38716.

4. Residual Solvents Add Risk To Drug Safety
   1/22/2019

   Improper handling of residual solvents adds risk to quality and safety. Lack of experience and constrained capacity compound it.

5. Extractables and Leachables Studies
   12/10/2018

   Regulations make extractables and leachables studies an essential part of your development process. Investigate the potentially harmful effects of your container/closure system on your drug product to assist in identifying the threat of contamination. 

6. Abbemat Heavy Duty Refractometers Brochure
   6/16/2015

   Anton Paar’s range of Abbemat refractometers embody over forty years of technical expertise. They are built with care and precision using the highest quality materials. Abbemat refractometers measure the refractive index and concentration of liquids, gels and solids. These truly universal refractometers cover a broad range of applications in all industries. Depending on the accuracy, temperature range and level of automation you require, a model is available to suit your application and your budget. An Abbemat is a secure investment for the future, providing reliable and accurate results for years to come.

7. Anton Paar Heavy Duty Refractometers
   6/16/2015
8. Used Perkin Elmer Elan 6100 ICP-MS Mass Spectrometer
   6/6/2019

   Used Perkin Elmer Elan 6100 ICP-MS mass spectrometer, serial# 1820006.

9. Analytical Development Services
   12/10/2018

   With thousands of methods developed, validated, and/or transferred in support of IND/ANDA/NDA/BLA applications, Nitto Avecia Pharma Services’ scientific team has a proven track record with nearly all drug forms, substances, and products.

10. Abbemat Heavy Duty Refractometers
    6/16/2015

    Technology leader Anton Paar launches two new high-performance refractometers: Abbemat 450 and 650. The instruments combine extraordinary robustness with high precision up to ±0.00002 nD to measure the refractive index under harsh conditions.