Clarithromycin USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 96 102.00% SPECIFIC ROTATION (20�C) -94� to -102� -94� to -102� CRYSTALLINITY TO PASS TEST TO PASS TEST pH 8 10 WATER DETERMINATION...
Ciprofloxacin Hydrochloride USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH OF A 1 IN 40 SOLUTION 3 4.5 WATER DETERMINATION 4.7 6.70% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED...
Miconazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST...
Sulfisoxazole Crystalline USP
Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 101.0% 99.0 - 101.0% MELTING RANGE 194� - 199�C 194� - 199�C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% SELENIUM...
Ketoprofen BP
Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST TO PASS TEST...
Meloxicam BP
Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% CLARITY OF SOLUTION TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST TO PASS TEST...
Trimeprazine Hemi-(+)-tartrate Salt BP
Test Specification Min Max ACIDTY (pH OF 2% IN WATER) 5 - 6.5 5 - 6.5 APPEARANCE WHITE OR SLIGHTL WHITE OR SLIGHTL ASSAY 99 - 101 % 99 -...
Buspirone Hydrochloride USP
Test Specification Min Max ASSAY 97.5 102.50% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES DETECTED AT (UV 240 nm): Bispirone related compound...
Cimetidine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 139 144�C LOSS ON DRYING 1.00% ORGANIC IMPURITIES TO PASS TEST RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED...
Metronidazole Meets B.P. 88 Specifications
Test Specification Min Max ASSAY (C[@6@]H[@9@]N[@3@]O[@3@]) 99 101.00% MELTING RANGE 159� 162�C RELATED SUBSTANCES TO PASS TEST LOSS ON DRYING 0.50% SULFATED ASH 0.10%
Pancrelipase USP
Test Specification Min Max LIPASE ACTIVITY 24 U/mg 24 U/mg AMYLASE ACTIVITY 100 U/mg 100 U/mg PROTEASE ACTIVITY 100 U/mg 100 U/mg MICROBIAL LIMITS TO PASS TEST TO PASS TEST...
Hydroxyzine Hydrochloride USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 5.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST...
Cholestyramine Resin USP
Test Specification Min Max EXCHANGE CAPACITY 1.8 2.2 g pH OF A 1 IN 100 SLURRY 4 6 CHLORIDE CONTENT 13 17.00% LOSS ON DRYING 12.00% RESIDUE ON IGNITION 0.10%...
Clonidine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 - 101.0 % 98.5 - 101.0 % pH OF A 5% SOLUTION 3.5 - 5.5 3.5 - 5.5 LOSS ON DRYING 0.50%...
Bupropion Hydrochloride USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 0.50% 3-CHLOROBENZOIC ACID TO PASS TEST TO PASS TEST ORGANIC IMPURITIES TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES...
Phenoxybenzamine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% MELTING RANGE 136 141 C LOSS ON DRYING 0.50% ORDINARY IMPURITIES 2.00% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION (A) SPECTRUM SPECTRUM IDENTIFICATION...
Clobetasol Propionate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% MELTING RANGE APPROX. 196�C APPROX. 196�C SPECIFIC ROTATION [a][@D@] +98� to +104� +98� to +104� LOSS ON DRYING 2.00% ORGANIC IMPURITIES...
Cisplatin USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% PLATINUM CONTENT (ANHYDROUS BASIS) 64.42 65.22% CRYSTALLINITY TO PASS TEST UV PURITY RATIO 4.5 WATER DETERMINATION 1.00% TRICHLOROAMMINEPLATINATE 1.00% TRANSPLATIN 2.00%...
Gabapentin USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% pH OF A 2% SOLUTION 6.5 8 WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED EARLY-ELUTING...
Methylprednisolone Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +97� to +105� +97� to +105� LOSS ON DRYING 1.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST...
Medroxyprogesterone Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +45� to +51� +45� to +51� LOSS ON DRYING 1.00% MEDROXYPROGESTRONE ACETATE[nRELATED COMPOUND A 0.50% ORGANIC IMPURITIES TO...
Promethazine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 101.50% pH OF A 1 IN 20 SOLUTION 4 5 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS...
Enalapril Maleate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION, [a][@D@]20 -41.0� to -43.5 -41.0� to -43.5 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES: LEAD (Pb)...
Diclofenac Sodium USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% COLOR OF SOLUTION TO PASS TEST TO PASS TEST CLARITY OF SOLUTION TO PASS TEST TO PASS TEST pH OF A...
Baclofen USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% WATER DETERMINATION 3.00% RESIDUE ON IGNITION 0.30% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST...
Triamcinolone Diacetate Micronized USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +39� to +45� +39� to +45� WATER DETERMINATION 6.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES AS REPORTED AS...
Omeprazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST LIMIT OF OMEPRAZOLE RELATED COMPOUNDS F AND G 350 PPM LOSS ON...
Fluorouracil USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% FLUOROURACIL RELATED COMPOUND F 0.25% UREA 0.20% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Meclofenamate Sodium USP
Test Specification Min Max ASSAY (C[@14@]H[@10@]Cl[@2@]NNaO[@2@]; ANHYDROUS BASIS) 97 103.00% WATER DETERMINATION 4.8 5.80% COPPER 0.00% CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Ketoconazole USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a][@D@] -1 to +1 -1 to +1 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED...
Furosemide USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST IDENTIFICATION TO...
Cyclobenzaprine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS...
Clotrimazole Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IMIDAZOLE 0.50% CLOTRIMAZOLE RELATED COMPOUND A 0.50%...
Cromolyn Sodium USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% ACIDITY OR ALKALINITY TO PASS TEST WATER DETERMINATION 10.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED OXALATE 0.35% RELATED COMPOUNDS 0.50% IDENTIFICATION...
Methacholine Chloride Crystal USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 101.00% IDENTIFICATION TO PASS TEST TO PASS TEST LOSS ON DRYING 1.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Betamethasone Dipropionate Micronized Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% SPECIFIC ROTATION [a][@D@] +63� to +70� +63� to +70� LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES TO PASS...
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.