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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>
Analytical Testing 01 01 - LGM Pharma

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
LGM May Blog 2 - LGM Pharma

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

cbox AnalyticalTesting - LGM Pharma

Analytical Testing Services

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

EXPLORE OUR TESTING CAPABILITIES
cbox API StrategicSourcing - LGM Pharma

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
cbox CDMO SemiSolid - LGM Pharma

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
HOW CAN WE HELP?
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