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Raw Materials / Compendial Testing...
Quantex Laboratories performs comprehensive
analytical testing of raw materials, active pharmaceutical ingredients,
excipients and finished pharmaceutical products. Our services can assist you in
the qualification of your vendors or in the release of raw materials for
production and manufacturing purposes. Compendial testing is performed in
accordance with USP/NF, BP, EP, JP, ACS and FCC methodologies and monographs, as
well as with client-supplied or vendor-specified methods.
Quantex’s highly trained scientists, in
conjunction with our considerable investment in laboratory resources, can handle
the analysis of significant quantities of samples. We maintain well equipped
state-of-the-art laboratories that routinely support the analysis of raw
materials including actives, fillers, binders, colors, and other excipients. All
our laboratory operations and procedures are based on written, detailed SOPs and
stringent quality assurance practices.
USP Chemical Tests
&
Assays |
USP Physical Tests
& Determinations |
<181> Identification –
Organic Nitrogenous
Bases |
<611> Alcohol
Determination |
<191> Identification
Tests - General |
<631> Color and
Achromicity |
<193> Identification
- Tetracyclines |
<641> Completeness of
Solution |
<197>
Spectrophotometric Identification Tests |
<643> Total Organic
carbon |
<201> TLC
Identification Test |
<645> Water
Conductivity |
<206> Aluminum |
<651> Congealing
Temperature |
<211> Arsenic |
<698> Deliverable
Volume |
<216> Calcium,
Potassium, and Sodium |
<731> Loss on Drying |
<221> Chloride and
Sulfate |
<741> Melting Range or
Temperature |
<231> Heavy Metals |
<781> Optical Rotation |
<241> Iron |
<785>
Osmolarity |
<251> Lead |
<786> Particle Size
Distribution |
<261> Mercury |
<788> Particulate
Matter in Injections |
<271> Readily
Carbonizable Substances |
<791> pH |
<281> Residue on
Ignition |
<831> Refractive Index |
<291>
Selenium |
<841> Specific Gravity |
<341> Antimicrobial
Agents Content |
<911> Viscosity |
Benzyl
Alcohol |
<921> Water
Determination |
Chlorobutanol |
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Phenol |
Microbiological
Testing |
Methylparaben and Propylparaben |
<61> Microbial Limit
Tests |
<401> Fats and Fixed
Oils |
<71> Sterility |
Specific
Gravity |
<85> Bacterial
Endotoxins |
Melting
Temperature |
|
Acid
Value |
Other |
Ester
Value |
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Hydroxyl
Value |
Iodine
Value |
Peroxide Value |
Saponification Value |
Fatty Acid
Composition |
<461> Nitrogen
Determination |
<466> Ordinary
Impurities |
<467> Residual
Solvents |
<591>
Zinc |
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| Testing Services... |
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Identification tests. |
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Assay (HPLC, GC). |
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Organic volatile impurities (USP<467>). |
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Residual Solvents (USP<467>). |
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1,4-Dioxane testing.
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Ethylene Oxide testing. |
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Spectroscopic analysis (FTIR and UV/VIS) |
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Water (Karl Fischer, volumetric and coulometric). |
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Heavy Metals. |
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Arsenic, Lead, Mercury. |
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Metals analysis using Flame Cold Vapor and Graphite Furnace Atomic Absorption spectroscopy, ICP and ICP-MS. |
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Physical-chemical (pH, viscosity, specific gravity, refractive index, optical and specific rotation, melting point, loss on drying, residue on ignition and congealing temperature |
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Titrimetry (potentiometric and visual end points). |
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Purified water and sterile water for injection testing. |
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USP microbial limits |
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Parabens |
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Sunscreens |
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