Methoxsalen USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% MELTING RANGE 143� - 148�C 143� - 148�C WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED CHROMATOGRAPHIC IMPURITIES...
Mebendazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...
Ergotamine Tartrate (DEA List I Chemical) USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 100.50% SPECIFIC ROTATION [a][@D@] -155� to -165� -155� to -165� LOSS ON DRYING 5.00% RELATED ALKALOIDS TO PASS TEST ELEMENTAL IMPURITIES TO...
Ranitidine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.5 102.00% pH OF A 1 IN 100 SOLUTION 4.5 6 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.75% RESIDUE ON IGNITION...
Pyrimethamine USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% MELTING RANGE 238� 242�C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORDINARY IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED...
Ipratropium Bromide BP EP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99.0 - 100.5 % 99.0 - 100.5 % APPEARANCE OF SOLUTION TO PASS TEST pH OF A 1% SOLUTION 5.0 - 7.5 5.0...
Chlorambucil USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% MELTING RANGE 65� 69�C WATER DETERMINATION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION...
Cefoperazone Sodium Antibacterial USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 870 - 1015 ug/mg 870 - 1015 ug/mg CRYSTALLINITY TO PASS TEST TO PASS TEST pH of a 1 in 4 Solution 4.5...
Calcium Gluceptate Hemiheptahydrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 95.0 - 102.0 % 95.0 - 102.0 % pH OF A 1 IN 10 SOLUTION 6.0 - 8.0 6.0 - 8.0 LOSS ON...
Azathioprine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS...
Hydrocortisone Hemisuccinate Monohydrate USP
Test Specification Min Max ASSAY (C[@25@]H[@34@]O[@8@]) 97.0 - 103.0 % 97.0 - 103.0 % SPECIFIC ROTATION [a][@D@] +124 to +134 +124 to +134 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS...
Thioridazine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% MELTING RANGE (WITHIN 3�C) 159� 165�C pH OF A 1 IN 100 SOLUTION 4.2 5.2 LOSS ON DRYING 0.40% CHROMATOGRAPHIC IMPURITIES...
Dorzolamide Hydrochloride USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 101.00% HEAVY METALS 10 ppm LIMIT OF DORAZOLAMIDE HYDROCHLORIDE RELATED COMPOUND A 0.50% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST RESIDUE...
Methylprednisolone Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +79 to +86 +79 to +86 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% RESIDUE ON IGNITION...
Betamethasone Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +120� to +128� +120� to +128� WATER DETERMINATION 4.00% RESIDUE ON IGNITION 0.20% ORDINARY IMPURITIES TO PASS TEST...
Prednisolone Anhydrous Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +97 to +103 +97 to +103 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00%...
Acetaminophen Granular USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: PLATINUM (Pt) AS REPORTED AS REPORTED FREE p-AMINOPHENOL 0.01% ORGANIC IMPURITIES TO PASS TEST TO...
Betamethasone Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +118 to +126 +118 to +126 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ORDINARY IMPURITIES TO PASS...
Chlorpheniramine Maleate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]25 -0.10 to +0.10� -0.10 to +0.10� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS...
Naproxen Sodium USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION -15.3� to -17.0 -15.3� to -17.0 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% ELEMENTAL...
Manganese Chloride Tetrahydrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% pH OF A 1 IN 20 SOLUTION 3.5 6 LOSS ON DRYING 36 38.50% INSOLUBLE MATTER 0.01% SULFATE 0.01% SUBS. NOT...
Dexamethasone Sodium Phosphate Powder USP
Test Specification Min Max ASSAY (Anhydrous Solvent-free Basis) 97 102.20% SPECIFIC ROTATION (Anhydrous Solvent-free Basis) +74� +82� pH (1% AQUEOUS SOLUTION) 7.5 10.5 WATER DETERMINATION 10.00% ALCOHOL 1.50% PHOSPHATE IONS...
Potassium Bicarbonate Granular USP
Test Specification Min Max ASSAY (KHCO[@3@]) 99.5 101.50% LOSS ON DRYING (OVER SILICA) 0.30% NORMAL CARBONATE 2.50% ELEMENTAL IMPURITIES: COBALT (Co) AS REPORTED ANTIMONY (Sb) AS REPORTED TIN (Sn) AS...
Methenamine USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% LOSS ON DRYING 2.00% RESIDUE ON IGNITION 0.10% CHLORIDE (Cl) 0.01% SULFATE TO PASS TEST AMMONIUM SALTS TO PASS TEST ELEMENTAL...
Thiabendazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% MELTING RANGE 296� 303�C CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% SELENIUM (Se) 0.00% ELEMENTAL...
Alprostadil USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 95 105.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.50% FOREIGN PROSTAGLANDINS, TEST 1 TO PASS TEST TO PASS TEST FOREIGN PROSTAGLANDINS, TEST 2...
Vancomycin Hydrochloride USP
Test Specification Min Max POTENCY (AS VANCOMYCIN) 900 �g/mg pH OF A 50 mg/ml SOLUTION @ 25[dC 2.5 4.5 COMPOSTION OF VANCOMYCIN TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...
Ursodiol USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% MELTING RANGE 200 205�C SPECIFIC ROTATION [a][@D@] +57� to +62� +57� to +62� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10%...
Verapamil Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH OF A 5% SOLUTION 4.5 6.5 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO...
Theophylline Anhydrous USP
Test Specification Min Max ASSAY 97 102.00% LOSS ON DRYING @ 105 C 0.50% ORGANIC IMPURITIES: . . THEOPHYLLINE RELATED COMPOUND C 0.10% THEOPHYLLINE RELATED COMPOUND B 0.10% THEOPHYLLINE RELATED...
Triamcinolone USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.0 - 102.0 % 97.0 - 102.0 % SPECIFIC ROTATION [a][@D@] +65 to +72 +65 to +72 LOSS ON DRYING 2.00% RESIDUE ON...
Triamcinolone Hexacetonide USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% OPTICAL ROTATION +91 to +98 +91 to +98 LOSS ON DRYING 2.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED TRIAMCINOLONE ACETONIDE 1.00%...
Tamsulosin Hydrochloride EP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% RELATED SUBSTANCES TO PASS TEST TO PASS TEST ENANTIOMERIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 0.50% SULFATED...
Tylosin Tartrate For Veterinary Use BP
Test Specification Min Max POTENCY (DRIED BASIS) 800 IU/mg pH OF A 2.5% AQUEOUS SOLUTION 5.0 - 7.2 5.0 - 7.2 COMPOSITION TO PASS TEST TO PASS TEST TYRAMINE 0.35%...
Active Pharmaceutical Ingredients
Chemical APIs (Active Pharmaceutical Ingredients)
Spectrum Chemical manufactures and distributes over 400 chemical APIs (active pharmaceutical ingredients. These substances are the biologically active component of any drug product regardless of pharmaceutical formulation type (tablets, capsules, topical, etc.). Spectrum Chemicals Australia specializes in providing the top active pharmaceutical ingredients for at least 40 therapeutic areas . All Spectrum Chemical active pharmaceutical ingredients are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities. Spectrum’s pledge to you is our products will be delivered to you with the quality and delivery you can count on every time. contact us.