Sodium Acetate Anhydrous USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 101.00% pH OF A 3% SOLUTION @ 25[dC 7.5 9.2 LOSS ON DRYING 1.00% INSOLUBLE MATTER 0.05% CHLORIDE (Cl) 350 ppm SULFATES...
Sodium Bicarbonate Powder USP EP BP JP
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% pH OF A 5% SOLUTION 7.9 8.4 LOSS ON DRYING 0.25% INSOLUBLE SUBSTANCES TO PASS TEST TO PASS TEST NORMAL CARBONATE...
Sodium Chloride Granular USP
Test Specification Min Max ASSAY (DRIED BASIS) 99 100.50% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST ACIDITY OR ALKALINITY TO PASS TEST TO PASS TEST LOSS ON DRYING...
Amitriptyline Hydrochloride US- (DGF) UN2811, 6.1, PG III
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH OF A 1 IN 100 SOLUTION 5 6 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED...
Dibasic Potassium Phosphate Anhydrous USP EP BP
Test Specification Min Max ASSAY (K[@2@]HPO[@4@]; DRIED BASIS) 98 100.50% pH OF A 1 IN 20 SOLUTION 8.5 9.6 LOSS ON DRYING 1.00% INSOLUBLE SUBSTANCES 0.20% CARBONATE TO PASS TEST...
Magnesium Sulfate Anhydrous USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 99 100.50% pH (IN SOLUTION 1 IN 20) 5 9.2 LOSS ON DRYING 2% CHLORIDE (Cl) 0.01% IRON 20 ug/g ELEMENTAL IMPURITIES: LEAD...
Lactic Acid Racemic USP, DG UN3265, 8, PG III
Please note this is a Dangerous Good and incurs a $350 Dangerous Goods Shipping Fee Test Specification Min Max ASSAY (C[@3@]H[@6@]O[@3@]) 88 92.00% SPECIFIC ROTATION -0.05 to +0.05� -0.05 to...
Magnesium Chloride Hexahydrate Crystal USP EP BP
Test Specification Min Max ASSAY 98 101.00% pH OF A 5% SOLUTION @ 25[dC 4.5 7 WATER 51 55.00% INSOLUBLE MATTER 0.01% SULFATE 0.01% BARIUM TO PASS TEST TO PASS...
Tobramycin Sulfate USP
Test Specification Min Max POTENCY (C[@18@]H[@37@]N[@5@]O[@9@]) 634 739 �g/mg pH 6 8 WATER DETERMINATION 2.00% RESIDUE ON IGNITION 1.00% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST...
Acetaminophen Powder 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 4-AMINOPHENOL 0.01% ORGANIC IMPURITIES TO PASS TEST TO...
Lidocaine Hydrochloride Monohydrate USP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 97.5 102.50% WATER DETERMINATION 5 7.00% RESIDUE AFTER IGNITION 0.10% SULFATE 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST...
Carbidopa USP
Test Specification Min Max ASSAY 98 102.00% SPECIFIC ROTATION [a][@D@] -21.0 to-23.5 -21.0 to-23.5 LOSS ON DRYING 6.9 7.90% RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED METHYLDOPA & 3-O-METHYLCARBIDOPA...
Progesterone Micronized Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 103.00% MELTING RANGE 126� 131�C SPECIFIC ROTATION, [a][@D@]25 +175� to +183� +175� to +183� PARTICLE SIZE (through 20 microns) 90% LOSS ON...
Benzocaine USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% LOSS ON DRYING 1.00% RESIDUE ON IGNITION 0.10% CHLORIDE TO PASS TEST ORGANIC IMPURITIES TO PASS TEST ELEMENTAL IMPURITIES: VANADIUM (V)...
Thimerosal USP EP BP
Test Specification Min Max ASSAY (DRIED BASIS) 97 102.00% ASSAY (DRIED BASIS; EP,BP) 97 101.00% pH 6 8 APPEARANCE OF SOLUTION CLEAR CLEAR LOSS ON DRYING 0.50% MERCURY IONS 0.70%...
Calcium Chloride Dihydrate USP EP BP JP
Test Specification Min Max ASSAY 99 103.00% pH OF A 5% SOLUTION 4.5 9.2 IRON, ALUMINUM, PHOSPHATE NO TURBIDITY OR NO TURBIDITY OR IRON (EP) 10 ppm ELEMENTAL IMPURITIES AS...
Monobasic Sodium Phosphate Anhydrous USP
Test Specification Min Max ASSAY (NaH[@2@]PO[@4@]); ANHYDROUS BASIS) 98 103.00% pH OF A 5% SOLUTION 4.1 4.5 WATER DETERMINATION 2.00% INSOLUBLE SUBSTANCES 0.20% CHLORIDE (Cl) 0.01% SULFATES (SO[@4@]) 0.15% Al,...
Miconazole Nitrate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% OPTICAL ROTATION -0.10??to +0.10 -0.10??to +0.10 LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.20% ORGANIC IMPURITIES ACCEPTANCE CRI DESCHLOROBENZYL ECONAZOLE 0.25%...
Lactic Acid Racemic USP
Test Specification Min Max ASSAY (C[@3@]H[@6@]O[@3@]) 88 92.00% SPECIFIC ROTATION -0.05 to +0.05‹¨« -0.05 to +0.05‹¨« RESIDUE ON IGNITION 0.05% SUGARS TO PASS TEST TO PASS TEST CHLORIDE TO PASS...
Aminophylline Anhydrous Powder BP EP
Test Specification Min Max THEOPHYLLINE (ANHYDROUS BASIS) 84 87.40% ETHYLENEDIAMINE (ANHYDROUS BASIS) 13.5 15.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST TO PASS...
Tizanidine Hydrochloride USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% pH 4.3 5.3 HEAVY METALS 20 ppm LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% ORGANIC IMPURITIES TO PASS TEST TO...
Ivermectin USP
Test Specification Min Max ASSAY (Sum of H[@2@]B[@1a@] and H[@2@]B[@1b@]; Dried, Alcohol & 95 102.00% & Formamide free Basis) RATIO (H[@2@]B[@1a@]/H[@2@]B[@1a@] + H[@2@]B[@1b@] 90% SPECIFIC ROTATION -17� to -20� -17�...
Guanabenz Acetate USP
Test Specification Min Max ASSAY 98.0 - 101.5 % 98.0 - 101.5 % pH 5.5 - 7.0 5.5 - 7.0 CHROMATOGRAPHIC PURITY TO PASS TEST LOSS ON DRYING 1.00% RESIDUE...
Formoterol Fumarate Dihydrate EP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98.5 101.50% pH OF 0.1% SOLUTION 5.5 6.5 OPTICAL ROTATION -0.10� to +0.10 -0.10� to +0.10 WATER 4 5.00% RELATED SUBSTANCES TO PASS...
Trimethoprim Powder USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.5 101.00% MELTING RANGE 199� 203�C LOSS ON DRYING 0.50% CHROMATOGRAPHIC PURITY TO PASS TEST RESIDUE ON IGNITION 0.10% ELEMENTAL IMPURITIES: NICKEL (Ni)...
Methazolamide USP
Test Specification Min Max ASSAY (DRIED BASIS) 98.0 - 102.0 % 98.0 - 102.0 % LOSS ON DRYING 0.50% RESIDUE ON IGNITION 0.10% HEAVY METALS 0.00% SELENIUM 0.00% IDENTIFICATION TO...
Silver Sulfadiazine Micronized USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SILVER CONTENT 29.3 30.50% LOSS ON DRYING 0.50% NITRATE 0.10% ORGANIC IMPURITIES . . SULFANILIC ACID 0.30% 2-AMINO-2-METHYL-1-PROPANOL 0.30% ACETYLSULFADIAZINE 0.20%...
Brompheniramine Maleate USP
Test Specification Min Max ASSAY (DRIED BASIS) 98 102.00% SPECIFIC ROTATION +0.2� to -0.2� +0.2� to -0.2� pH OF A 1% SOLUTION 4 5 LOSS ON DRYING 0.50% RESIDUE ON...
Theobromine EP
Test Specification Min Max ASSAY (DRIED BASIS) 97 101.00% ACIDITY To pass test LOSS ON DRYING 0.50% RELATED SUBSTANCES To pass test SULFATED ASH 0.10% APPEARANCE RESIDUAL SOLVENTS To pass...
Piperazine Adipate BP EP
Test Specification Min Max ASSAY (ANHYDROUS BASIS) 98 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST RELATED SUBSTANCES TO PASS TEST TO PASS TEST WATER 0.50% SULFATED ASH...
Piperazine Hydrate BP EP
Test Specification Min Max ASSAY 98 101.00% APPEARANCE OF SOLUTION TO PASS TEST TO PASS TEST pH OF A 5% SOLUTION 10.5 12 RELATED SUBSTANCES TO PASS TEST TO PASS...
Reserpine USP
Test Specification Min Max ASSAY (DRIED BASIS) 97 101.00% LOSS ON DRYING @ 60�C 0.50% RESIDUE AFTER IGNITION 0.10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED IDENTIFICATION TO PASS TEST TO...
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.