SECONDARY REFERENCE STANDARDS

(1)

WHY SHOULD YOU USE THEM?

• Economical: Attractively priced, representing a substantial saving over Pharmacopeial Reference Standards or in-house standards.

• Generous Quantities: Product contains 2-20x the amount offered by the Pharmacopeias, allowing multiple uses.

• Mitigates Risk: Standards are supplied by an independent 3rd party RM specialist working to cGMP and ISO standards.

• Effi cient: Focus resources on value producing activities, rather than the routine.

OUR QUALITY SYSTEM ENSURES A PRODUCT YOU CAN DEPEND ON

• Comprehensive Documentation: The Certifi cate of Analysis provided complies with the requirements of ISO Guide 31 and is traceable to the relevant United States, European, and where appropriate British Pharmacopeial Reference Standard.

• ISO Conforming: Produced and certifi ed in accordance with ISO 17025 and ISO Guide 34.

• cGMP Production: Packaged and produced in a clean room facility utilizing GMP processes and documentation practices.

FOR PHARMACEUTICAL ANALYSIS

Pharma

TM

오디랩 T.02-809-7848, 엄영록HP:011-695-4916

(2)

Price List

Catalog Number Description Unit Size Unit Price Pack Size Pack Price

PHR-1005 Acetaminophen (Paracetamol) 1 g $35 5 $155

PHR-1008 Ascorbic Acid 2 g $40 5 $177

PHR-1003 Aspirin (Acetylsalicylic acid) 1 g $35 5 $155

PHR-1022 Butylparaben (Butyl parahydroxybenzoate) 1 g $35 5 $155

PHR-1009 Caff eine 1 g $35 5 $155

PHR-1000 Dextrose (D-Glucose) 1 g $35 5 $155

PHR-1011 Ethylparaben (Ethyl parahydroxybenzoate) 1 g $35 5 $155

PHR-1004 Ibuprofen 1 g $35 5 $155

PHR-1007 Mannitol 1 g $35 5 $155

PHR-1012 Methylparaben (Methyl parahydroxybenzoate) 1 g $35 5 $155

PHR-1010 Propylparaben (Propyl parahydroxybenzoate) 1 g $35 5 $155

PHR-1013 Salicylic Acid 1 g $35 5 $155

PHR-1006 Sorbitol 1 g $35 5 $155

PHR-1027 Guaifenesin 1 g $35 5 $155

PHR-1019 Benzyl Alcohol 1 g

PHR-1016 Chlorpheniramine Maleate 500 mg

PHR-1038 Clarithromycin 500 mg

PHR-1021 Clindamycin Phosphate 1 g

PHR-1018 Dextromethorphan Hydrobromide 500 mg PHR-1015 Diphenhydramine Hydrochloride 1 g

PHR-1039 Erythromycin 500 mg

PHR-1035 Folic Acid 1 g

PHR-1002 Fructose 1 g

PHR-1020 Glycerin 5 g

PHR-1032 Hydrochlorothiazide 500 mg

PHR-1014 Hydrocortisone 500 mg

PHR-1025 Lactose (anhydrous) 1 g

PHR-1024 Lactose monohydrate 1 g

PHR-1034 Lidocaine 1 g

PHR-1033 Niacinamide 1 g

PHR-1017 Phenylephrine Hydrochloride 500 mg PHR-1036 Pyridoxine Hydrochloride 500 mg PHR-1026 Ranitidine Hydrochloride 500 mg

PHR-1001 Sucrose 1 g

PHR-1023 Theophylline 1 g

PHR-1037 Thiamine Hydrochloride 1 g

PHR-1028 1,4-Benzoquinone 1 g

PHR-1031 α-Tocopherol 500 mg

PHR-1030 α-Tocopheryl Acetate 500 mg PHR-1029 α-Tocopheryl Succinate 500 mg

Available Soon

Worldwide, excluding Europe and India A. Lee Lang -- Business Development RT Corporation

[email protected] 800-576-5690 307-742-5452

Alan Nichols -- Technical RT Corporation

[email protected]

Europe and India Peter Jenks Tecnical Manager RT Corporation Ltd +44 1722 711722 [email protected]

RT-Corp.com

US FDA: Guidance for Industry; Analytical Procedures and Methods Validation; Chemistry, Manufacturing, and Controls Documentation;

Draft Guidance http://www.fda.gov/cder/guidance/2396dft.htm. “A reference standard (i.e., primary standard) may be obtained from the USP/NF or other offi cial sources (e.g., CBER, 21 CFR 610.20). A working standard (i.e., in-house or secondary standard) is a standard that is qualifi ed against and used instead of the reference standard.”

USP: USP31-NF26: General Chapter <1010> Analytical Data-Interpretation and Treatment: “Use of Reference Standards: Where the use of USP Reference Standards is specifi ed, the USP Reference Standard, or a secondary standard traceable to the USP Reference Standard, is used.”

EP: European Pharmacopoeia 6th Edition 2008: Chapter 5.12. REFERENCE STANDARDS “Secondary standard. A standard established by comparison with a primary standard. Secondary standard. A secondary standard may be used for routine quality control purposes for any of the uses described above for primary standards provided that it is established with reference to the primary standard.”

RT Pharma brand Secondary Standards: designed and produced to meet your needs.

Contact us:

The use of Secondary Reference Standards is Recognized by Regulatory Authorities

오디랩 T.02-809-7848, 엄영록HP:011-695-4916