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USP & General Tests

The USP establishes primary standards for ensuring quality in pharmaceutical development & manufacturing.

USP Reference Standards are rigorously tested and evaluated by multiple independent commercial, regulatory, and academic laboratories to confirm accuracy and reproducibility.

USP Tests

Below are the most common general chapter tests we perform. We also perform many analyses by partial or full monographs in the official USP.

<2021>Microbial Enumeration Testing • Total Aerobic Microbial Count • Total Yeasts and Molds Count

USP
Chapter
Test
<61><62>Suitability Testing • Suitability of the Counting Methods in the Presence of Product. • Suitability of the Test Methods in the Presence of Product.
<2021><2022>Preparatory Testing
<51>Antimicrobial Effectiveness Testing
<60>Burkholderia cepacia complex (Bcc)
<61>Microbial Enumeration Testing • Total Aerobic Microbial Count • Total Yeasts and Molds Count
<62>Bile Tolerant Gram Negative Bacteria
<62>Escherichia coli (E.coli)
<62>Salmonella
<62>Pseudomonas aeruginosa Staphylococcus aureus
<62>Clostridia
<62>Candida albicans
<85>Endotoxins
<197>Spectrophotometric Identification Test
<201>Thin-Layer Chromatography Identification Test
<211>Arsenic
<221>Chloride and Sulfate
<228>Ethylene Oxide and Dioxane
<232>Elemental Impurities – Limits
<233>Elemental Impurities – Procedures
<241>Iron
<251>Lead
<281>Residue On Ignition
<291>Selenium
<301>Acid Neutralizing Capacity
<311>Alginates Assay
<401>Fats and Fixed Oils
• Acid Value, Sap Value, Hydroxyl value, Iodine value (method I & II), Unsap value, Fatty Acid Composition. Omega-3 Fatty Acids Determination and Profile, Peroxide value
<467>Organic Volatile Impurities
<469>Ethylene Glycol. Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances
<471>Oxygen Flask Combustion
<525>Sulfur Dioxide
<541>Titrimetry
<616>Bulk Density And Tapped Density Of Powder
<621>Chromatography (GC. HPLC and HPTLC)
<643>Total Organic Carbon
<645>Water Conductivity
<651>Congealing Temperature
<671>Moisture Permeation (Blister Packs)
<701>Disintegration
<711>Dissolution
<721>Distilling Range
<731>Loss On Drying
<733>Loss On Ignition
<741>Melting Range or Temperature
<781>Optical Rotation
<786:>–Particle Size Distribution Estimation by Analytical Sieving
<791>pH
<831>Refractive Index
<841>Specific Gravity
<851>Spectrophotometry and Light-Scattering
<905>Uniformity of Dosage Units
<911>Viscosity-Capillary Viscometer
<912>Viscosity-Rotational Rheometer Methods
<921>Water Determination
<2021>Bile Tolerant Gram Negative Bacteria
<2022>Escherichia coli (E.coli)
<2022>Salmonella
<2022>Staphylococcus aureus
<2022>Clostridia
<2040>Disintegration and Dissolution of Dietary Supplements
<2091>Weight Variation of Dietary Supplements

General Tests

We also perform other analyses, including:

Acetyl Cysteine in Finished Products Alpha Lipoic Acid in Finished Products
Aqueous titrations
Average Molecular Weight
Benzocaine in Finished Products
Benzalkonium Chloride (BAK in finished Products)
Calories
Capsaicin in Liniment
Carbohydrate Analysis
Cholesterol Analysis
Choline Bitartrate In Finished Products
Cleaning Validations (TOC, UV HPLC, ICP-MS)
Coenzyme Co-QlO in Finished Products
Conjugated Linoleic Acid (CLA}
Cough Syrup (De>..tromethorphan HBr and Phenylephrine HCI)
ECGC in Green Tea
Fatty Acid Analysis
Fatty Acid Composition, Omega-3 Fatty Acids Determination
Fluoride analysis (in tooth paste and dental gels)
Formaldehyde Analysis
Heavy Metals by ICP-MS
Hydroxy Propoxy Determination (GC-TCD)
Hydroxypropo>..-y Groups
K Value (viscosity) Lecithin Assay
Levocarnitine (L-Carnitine) in Finished Products
Lidocaine in Creams and Ointments
Limit of Aldehydes{Copovldone and Povidone)
Limit of Sulfur Dioxide
Non-aqueous titrations
Optical and Specific Rotation (wavelengths available: 365 nm, 405 nm, 436 nm, 546 nm. 589 nm. 633 nm)
Organic and Inorganic Arsenic
Polyphenols (identification or quantitatively)
Proanthocyanides Assay in Grape Seed
Protein Analysis (Dumas method)
Quatemium (Dowacil-200)
Quercetin In Finished Products
Salicylic Acid in Finished Products
Stability Studies at CRT and Accelerated Conditions – CRT = 25C, 60% RH Accelerated = 40C, 75% RH Sterol Composition (GC)
Sunscreen Analysis in Finished Products – Octinoxate. Avobenzone, Octocrylene. Cxybenzone. Octisalate. Homosalate. Ensulizole
Titanium Dioxide (Ti02) Assay
Total Alk-ylbenzydlniethylammonium Chlor1des in Benzalkoniru11Chlor1de
Total Fats (Soxhlet)
Undecylenic Acid in Finished Products