Acyclovir USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% GUANINE 0.70% WATER DETERMINATION 6.00% ORDINARY IMPURITIES 1% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE...
Valproic Acid USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 102.00% ORGANIC IMPURITIES TO PASS TEST TO PASS TEST WATER DETERMINATION 1.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED...
Loperamide Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0 % 98.0 - 102.0 % CHLORIDE (Cl) 13.52 - 14.20 % 13.52 - 14.20 % CHROMATOGRAPHIC PURITY TO PASS TEST...
Cyproheptadine Hydrochloride USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 100.50% WATER DETERMINATION 7 9.00% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS...
Apomorphine Hydrochloride Hemihydrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% SPECIFIC ROTATION [a][@D@] -48� to -52� -48� to -52� LOSS ON DRYING 2 4.20% COLOR OF SOLUTION TO PASS TEST TO...
Captopril USP
Test Specification Min Max ASSAY (DRIED BASIS) 97.5 102.00% SPECIFIC ROTATION [a][@D@] -125 to -134 -125 to -134 LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES AS REPORTED...
Atenolol USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% MELTING RANGE 152� 156.5� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% CHLORIDE (Cl) 0.10% ORGANIC IMPURITIES TO PASS TEST ELEMENTAL...
Hydrocortisone Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION @ 20 C +158� to +167� +158� to +167� LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ORGANIC IMPURITIES...
Hydroxyurea USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.50% ELEMENTAL IMPURITIES: NICKEL (Ni) AS REPORTED AS REPORTED MOLYBDENUM (Mo) AS REPORTED AS...
Piroxicam USP
Test Specification Min Max ASSAY 97 103.00% WATER DETERMINATION 0.50% RESIDUE ON IGNITION 0.30% ELEMENTAL IMPURITIES AS REPORTED IDENTIFICATION TO PASS TEST RETEST DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS...
Niacin Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.00% 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% CHLORIDE (Cl) 0.02% SULFATES (SO[@4@]) 0.02% ELEMENTAL IMPURITIES: CADMIUM (Cd) AS REPORTED LEAD...
Potassium Gluconate Anhydrous USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% LOSS ON DRYING 3.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED REDUCING SUBSTANCES 1.00% IDENTIFICATION TO PASS TEST EXPIRATION DATE DATE OF...
Xylazine Hydrochloride USP
Test Specification Min Max ASSAY 98 102.00% MELTING RANGE 164� 168�C pH (1% IN WATER) 4 6 CHROMATOGRAPHIC PURITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% RESIDUE...
Chlorobutanol Anhydrous NF
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 100.50% REACTION (to LITMUS) NEUTRAL NEUTRAL WATER DETERMINATION 1.00% CHLORIDE 0.07% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION A TO PASS TEST...
Flunixin Meglumine USP
Test Specification Min Max ASSAY 98 102.00% pH (1 IN 20) 7 9 SPECIFIC ROTATION [a][@D@] -9� to -12� -9� to -12� LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20%...
Naphazoline Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH OF A 1 % SOLUTION @ 25[dC 5 6.6 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES: TO...
Aspirin USP
Test Specification Min Max ASSAY (C[@9@]H[@8@]O[@4@]) 99.5 100.50% LOSS ON DRYING 0.50% READILY CARBONIZABLE SUBSTANCES NO MORE NO MORE RESIDUE ON IGNITION 0.05% SUBSTANCES INSOLUBLE IN SODIUM CARBONATE SOLUTION IS...
Dehydrocholic Acid USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE (MAX. 3 C RANGE) 231 242�C SPECIFIC ROTATION [a][@D@] +29.0 to +32.5� +29.0 to +32.5� MICROBIAL LIMITS TO PASS...
Acetylcysteine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION [a][@D@] +21 to +27 +21 to +27 pH OF A 1 IN 100 SOLUTION 2 2.8 LOSS ON DRYING...
Hydrocortisone Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a]D25 +150� to +156� +150� to +156� PARTICLE SIZE (THROUGH 15 micron) 90% LOSS ON DRYING 1.00% RESIDUE ON...
Trichlormethiazide USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% SELENIUM (Se) 0.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED DIAZOTIZABLE SUBSTANCES 2.50% IDENTIFICATION...
Prednisolone Sodium Phosphate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 96 102.00% SPECIFIC ROTATION, [a][@D@]25 +95� to +102� +95� to +102� pH OF A 1 IN 100 SOLUTION 7.5 10.5 WATER DETERMINATION 6.50%...
Prednisolone Acetate Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% SPECIFIC ROTATION [a][@D@] +112 to +119 +112 to +119 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% ELEMENTAL IMPURITIES: NICKEL...
Estradiol Plant Base Micronized USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97 103.00% MELTING RANGE 173� 179�C SPECIFIC ROTATION [a][@D@]25 +76� to +83� +76� to +83� PARTICLE SIZE (THROUGH 20 micron) 92% WATER DETERMINATION...
Oxybutynin Chloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% CHLORIDE CONTENT (DRIED BASIS) 8 10% LOSS ON DRYING 3% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED AS...
Isoxsuprine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% pH OF A 1 IN 100 SOLUTION 4.5 6 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ELEMENTAL IMPURITIES: PALLADIUM (Pd)...
Sulindac USP
Test Specification Min Max ASSAY (C[@20@]H[@17@]FO[@3@]S; DRIED BASIS) 98 102.00% LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO...
Potassium Chloride Crystal USP
Test Specification Min Max ASSAY 99 100.50% ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST LOSS ON DRYING 1.00% BROMIDE 0.10% IODIDE 0.01% CALCIUM AND MAGNESIUM TO PASS TEST...
Ketoprofen Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 92.0� 97.0� SPECIFIC ROTATION, [a][@D@]25 +1� to -1� +1� to -1� LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO PASS...
Mefenamic Acid BP
Test Specification Min Max ASSAY (C[@15@]H[@15@]NO[@2@]; DRIED BASIS) 99 101.00% RELATED SUBSTANCES TO PASS TEST TO PASS TEST COPPER (Cu) 10 ppm LOSS ON DRYING 0.50% SULPHATED ASH 0.10% ELEMENTAL...
Doxapram Hydrochloride Monohydrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 3 4.50% pH 3.5 5 ORGANIC IMPURITIES TO PASS TEST TO PASS TEST RESIDUE ON IGNITION 0.30% HEAVY...
Amantadine Hydrochloride USP
Test Specification Min Max ASSAY 98.5 101.50% CLARITY AND COLOR OF SOLUTION TO PASS TEST TO PASS TEST pH OF A 20% SOLUTION 3 5.5 ORGANIC IMPURITIES TO PASS TEST...
Itraconazole Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.50% OPTICAL ROTATION, [a] 20D -0.10 to +0.10 -0.10 to +0.10 RESIDUE ON IGNITION 0.10% LOSS ON DRYING 0.50% ORGANIC IMPURITIES TO...
Tinidazole 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 ORGANIC IMPURITIES . . TINIDAZOLE RELATED COMPOUND A 0.20%...
Flurbiprofen USP
Test Specification Min Max ASSAY (DRIED BASIS) 99.0 - 100.5% 99.0 - 100.5% MELTING RANGE 114� - 117�C 114� - 117�C LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL...
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.