USP, NF, and FCC Products for Pharmaceutical and Biotechnology Processes

Pharmaceutical and biotechnology companies trust Mallinckrodt USP, NF and FCC products in their production processes for many reasons: product quality, traceability, documentation, quality audits, product availability and innovative packaging. Most importantly, the Mallinckrodt grade designation of USP, NF or FCC ensures that these products not only meet the appropriate compendial specifications, but also that the products are manufactured under documentable current Good Manufacturing Practices (cGMP) in an FDA-inspected* facility. We offer two grades to suit your specific needs:

USP or NF

• Manufactured under cGMP
• Meets requirements of the USP 24 or NF 19

USP/GenAR® or NF/GenAR®

• Manufactured under cGMP
• Meets requirements of the USP 24 or NF 19
• Tested against all European Pharmacopeia (EP) and British Pharmacopeia (BP) specifications where designated
• Endotoxin (LAL) tested where appropriate

*Registration does not denote FDA approval of a firm or product

Multicompendial Testing

The USP/GenAR line was developed to aid our customers as they prepare for production or clinical trials in Europe. These products are tested for each and every specification of the USP, EP and BP to ensure full compliance. Many suppliers do not repeat similar tests required by the various compendia, saving themselves money but not providing the full testing you require. Mallinckrodt's Certificate of Analysis is segregated according to compendia to meet your quality assurance needs. Our standard products are listed on the following pages. We can also perform custom EP/BP testing, please inquire.

Additionally, our USP and USP/GenAR products are available in Beaker to Bulk packaging - identical product in sizes suitable for R&D through full production to speed your scale-up development. Select hygroscopic salts, those products with a tendency to cake and develop a rock-hard consistency, are now available in patented FLOWMOR® packaging. This unique Mallinckrodt innovation provides conveniently free-flowing salts for easier handling.

Description	Product Number
Acetic Acid, 36%	2488
Acetic Acid, Glacial	2504
Acetic Acid, Glacial	3121
Acetone	2432
Ammonia Solution, Strong	3248
Ammonium Chloride, Granular	3364
Ammonium Sulfate, Granular	3496
Antimony Potassium Tartrate, Trihydrate, Powder	2388
Ascorbic Acid	1852
Ascorbic Acid, Very Fine Powder	8829
Barium Sulfate	8821
Barium Sulfate, For Formulation	4518
Benzoic Acid, Crystal	0108
Benzyl Alcohol	1403
Bismuth Subgallate, Powder	0304
Bismuth Subnitrate, Powder	0308
Bismuth Subsalicylate	4240
Boric Acid, Granular	1394
Boric Acid, Granular	7779
Butylparaben	7558
Calamine, Powder	4032
Calcium Acetate	1658
Calcium Acetate	2003
Calcium Acetate Dried Powder	1660
Calcium Acetate, Agglomerate	3754
Calcium Carbonate, Precipitated Light Powder	4052
Calcium Chloride, Dihydrate, Granular	4616
Calcium Chloride, Dihydrate, Granular	7722
Calcium Hydroxide, Powder	4188
Calcium Oxide	4268
Calcium Phosphate, Dibasic, Anhydrous, Powder	4264
Calcium Phosphate, Tribasic, Powder	4280
CalPlusTM (Brand of Calcium Chloride Dihydrate)	4842
CALTAC	4880
Charcoal, Activated, Powder	4394
Citric Acid, Monohydrate, Granular	0616
Citric Acid, Monohydrate, Granular	7788
Collodion	4560
Collodion, Flexible	4580
Cupric Sulfate, 5-Hydrate	7790
Cupric Sulfate, 5-Hydrate, Granular	4752
Dextrose, Anhydrous, Granular	4908
Dextrose, Anhydrous, Granular	7730
Edetate Disodium	1395
Edetate Disodium	7727
Ether	0812
Ether, For Anesthesia	0804
Ethylparaben	6882
Ferric Subsulfate Solution	6430
Ferrous Sulfate	5098
Ferrous Sulfate, 7-Hydrate, Granular	5572
Ferrous Sulfate, Dried, Monohydrate, Fine Powder	5051
Ferrous Sulfate, Dried, Monohydrate, Fine Powder	5075
Formaldehyde Solution	5014
Glycine	5104
Hydrochloric Acid	2062
Hydrochloric Acid	2515
Hydrochloric Acid	2626
Hydrochloric Acid (HCl 36.5%-38.0%)	2612
Hydrochloric Acid, Diluted	2608
Hydrocortisone, Micronized	8830
Hydrogen Peroxide, Topical Solution	5232
Hypophosphorous Acid, 30%	2660
Iodine, Crystal	0975
Iodine, Crystals	0984
Iron Reduced, Extra Fine Powder	4348
Iron Reduced, Fine Powder	4353
Isopropyl Alcohol	3031
Kaolin, Colloidal, Powder	5645
Lactic Acid, 88%	2672
Lactose, Monohydrate, Powder	6270
Magnesium Carbonate, Heavy Powder	5946
Magnesium Carbonate, Powder	5942
Magnesium Chloride, 6-Hydrate	5956
Magnesium Chloride, Flakes	5954
Magnesium Hydroxide, Powder	5984
Magnesium Oxide, Heavy Powder	6010
Magnesium Oxide, Powder	6018
Magnesium Stearate, Hyqual®, Vegetable Source	2257
Magnesium Stearate, Hyqual®, Vegetable Source	5712
Magnesium Stearate, Impalpable Powder Hyqual®	2256
Magnesium Sulfate, 7-Hydrate	4200
Magnesium Sulfate, 7-Hydrate	6046
Magnesium Sulfate, 7-Hydrate	7778
Magnesium Sulfate, 7-Hydrate, (For Parenteral Use)	5691
Magnesium Sulfate, Anhydrous, Powder	5053
Magnesium Sulfate, Dried Powder	6050
Mannitol, Powder	6208
Mannitol, Powder	7781
Menthol, Crystal	6222
Methenamine, Granular	5180
Methyl Alcohol	8814
Methyl Salicylate	2064
Methylparaben	6215
Mineral Oil, White, Heavy	6357
Mineral Oil, White, Light	6358
Phenol Liquefied	0610
Phenol, Crystal	0605
Phenol, Liquefied	0221
Phosphoric Acid	2788
Pilocarpine Nitrate	6662
Polysorbate 80	7091
Potassium Acetate, Crystal	6696
Potassium Acetate, Crystal	7797
Potassium Bicarbonate, Granular	6732
Potassium Bicarbonate, Powder	6736
Potassium Chloride Dialysate	6841
Potassium Chloride, Crystal	6845
Potassium Chloride, Granular	6838
Potassium Chloride, Special	7590
Potassium Citrate, Monohydrate, Granular	0714
Potassium Hydroxide, Pellets	6976
Potassium Hydroxide, Pellets	7815
Potassium Iodide, Granular	1112
Potassium Iodide, Powder	1115
Potassium Metabisulfite, Granular	7000
Potassium Permanganate, Crystal	7056
Potassium Phosphate, Monobasic, Crystal	7096
Potassium Phosphate, Monobasic, Crystal	7746
Potassium Sodium Tartrate, 4-Hydrate, Powder	2370
Potassium Sulfate	7132
Potassium Sulfate, Granular	7128
Propylene Glycol	6263
Propylparaben	7624
Resorcinol, Fine Powder	7232
Saccharin Sodium, Soluble	7260
Salicylic Acid, Powder	2020
Sodium Acetate, Trihydrate	7768
Sodium Acetate, Trihydrate, Granular	7356
Sodium Benzoate	0168
Sodium Benzoate, Dense	1331
Sodium Benzoate, Dust Free	1454
Sodium Bicarbonate, Powder	7396
Sodium Bicarbonate, Powder	7749
Sodium Bisulfite	7444
Sodium Borate, 10-Hydrate	7418
Sodium Borate, 10-Hydrate	7792
Sodium Chloride, Granular	4577
Sodium Chloride, Granular	7532
Sodium Chloride, Granular	7713
Sodium Chloride, Powder	7540
Sodium Citrate Dihydrate Crystalline	0634
Sodium Citrate, Dihydrate, Crystal	0734
Sodium Citrate, Dihydrate, Crystal	7773
Sodium Fluoride, Powder	5325
Sodium Hydroxide, Pellet	7680
Sodium Hydroxide, Pellet	7772
Sodium Metabisulfite, Granular	7776
Sodium Phosphate, Dibasic, 7-Hydrate, Granular	7393
Sodium Phosphate, Dibasic, 7-Hydrate, Granular	7896
Sodium Phosphate, Dibasic, Anhydrous	7771
Sodium Phosphate, Monobasic, Monohydrate	7774
Sodium Phosphate, Monobasic, Monohydrate, Granular	7868
Sodium Salicylate, Powder	2094
Sodium Sulfate, 10-Hydrate, Granular	8012
Sodium Sulfate, Anhydrous	8026
Sodium Sulfate, Anhydrous	8028
Sodium Sulfate, Anhydrous Milled Powder	8025
Sodium Sulfate, Anhydrous, Powder	7803
Sodium Thiosulfate, 5-Hydrate, Crystal	7763
Stearic Acid 50, Powder	2216
Stearic Acid, Powder	2236
Sucrose	7723
Sulfur, Precipitated	8400
Sulfuric Acid Babcock	3780
Talc	8476
Tannic Acid	1674
Tartaric Acid, Fine Granular	2307
Thiamine Hydrochloride	2722
Thymol, Crystal	8528
Tricalcium Phosphate, Micronized	3599
Urea	7816
Urea	8642
Zinc Chloride, Granular	8772
Zinc Oxide, Powder	8824
Zinc Sulfate, 7-Hydrate, Granular	8872