Analytical Laboratory in Irvine, California

Analytical Testing Services for Compounders

Testing Services for 503A & 503B Compounders

Compounding teams face increasing scrutiny, tighter timelines, and limited in-house lab capacity. For 503A pharmacies and 503B outsourcing facilities, partnering with contract analytical laboratories helps protect patient safety and meet regulatory expectations.

  • Ensure accuracy and reliability in every dosage form
  • Maintain compliance with USP <795>/<797>/<800>, and 21 CFR Parts 210/211
  • Prepare for inspections with traceable, defensible data
  • Reduce risk of recalls, deviations, and batch failures

LGM Pharma supports the analytical testing needs at our Irvine, CA facility.

  • FDA-inspected
  • cGMP-compliant
  • ISO 9001-certified
  • DEA-registered for controlled substances

Our team offers a comprehensive suite of testing services for compounders:

Microbiology (Sterile & Non-Sterile)

  • Sterility USP <71>
    Rapid sterility (5–7 day TAT) USP <1223>
  • Bacterial Endotoxins (BET) USP <85>
  • Microbial Enumeration USP <61>
  • Specified/Objectionable Organisms
    USP <62>
  • Antimicrobial Effectiveness (AET)
    USP <51>

Method Services (Quality System)

  • Method Validation (new/non-compendial) USP <1225>, ICH Q2(R1)
  • Method Verification (adopted compendial) USP <1226>
  • Method Transfer (to/from CTL)
    USP <1224>
  • Data Integrity 21 CFR Part 11
  • Microbial Method Suitability
    USP <61>/<62>/<71>/<85>

Chemistry & Stability

  • Assay/Impurities (HPLC/UPLC) USP <1225>/<1226>
  • Content Uniformity USP <905>
  • Residual Solvents USP <467>
  • Elemental Impurities (ICP-MS) USP <232>/<233>
  • Moisture (Karl Fischer/LOD) compendial methods
  • 503B Expiry Dating 21 CFR 211.166
  • Stability-Indicating Methods (SIMs)
    ICH Q2/USP <1225>
  • 503A BUD Frameworks USP <795>/<797>
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Blog: Compounding Compliance for 503A & 503B

Read this comprehensive guide to analytical testing for 503A Pharmacies and 503B Outsourcing Facilities

READ THE COMPOUNDER’S TESTING GUIDE
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Webinar: Practical Testing for Compounders

Join Shailesh Vengurlekar, SVP of Quality & Regulatory Affairs, in this focused webinar on 503A & 503B analytical testing considerations.

WATCH 30-MINUTE WEBINAR ON-DEMAND

LGM Pharma Core Services

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Analytical Testing Services

We tailor our services based on the unique regulatory requirements of various segments of the pharma industry.

EXPLORE OUR TESTING CAPABILITIES
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API Sourcing & Supply Chain Management

We leverage our network of over 220 pre-qualified API manufacturers and handle all logistics and regulatory requirements.

EXPLORE OUR API PRODUCT 
CATALOGUE
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Drug Product CDMO Services

We provide U.S.-based development and manufacturing of solid, liquid, semi-solid, and suppository dosage forms.

EXPLORE OUR DRUG PRODUCT CDMO SERVICES
Announcement that LGM Pharma has acquired Sannova Analytical, noting that Sannova will continue operations under its own name in Somerset, NJ.