PURITAN PRODUCTS
ADVANTAGE
Buying chemical raw materials should be easy, and that is how P2 makes it. Since 1987 we have provided outstanding service, because we believe in providing our customers with the service we would want for ourselves. Our products and systems are designed to help you reduce the time, costs and risks associated with managing a global chemical raw material supply chain from qualification to production. At Puritan Products, cGMP manufacturing means more than just FDA regulations, it’s our culture.
Get what you want, how you want it, when you want it. It’s just that simple. • cGMP manufacturing
• Flexible risk mitigation planning
• FDA registered and inspected facility
• Tamper evident packaging
• Full traceability and regulatory support
• Custom or unit dose packaging available
• MOC with notification
All PharmaPUR® and MultiPUR® products are: • Suitable for use as raw materials and excipients in pharmaceutical and biopharmaceutical manufacturing applications
• Packaged to excipient and non-sterile excipient requirements Lehigh Valley Industrial Park I • 2290 Avenue A • Bethlehem, PA 18017 Phone: 877.778.7482 • Fax: 610.866.4270 www.puritanproducts.com
The Puritan Promise • Collaborative Business Partner
• Industry Knowledge Experts
• Consistent Lead Times
• Streamlined Business Experience
• Superior Customer Satisfaction
• Responsive
• Flexible
• Hazardous Chemical Handling
• Resourceful
• Accessible
cGMP-Manufactured Products for Pharmaceutical and Biopharmaceutical Applications
Get what you want, how you want it, when you want it. It’s just that simple. With Puritan Products, chemical buying is made easy.
“Puritan is our sole supplier. No one else has what they have in their arena.” © 2017 by Puritan Products, Inc. All rights reserved.
PharmaPUR® Sodium Hydroxide Solutions
PharmaPUR® pH Buffers and Conductivity Standards
cGMP Biological Buffer Salts
• Only cGMP-Manufactured products available in the industry
• Cell culture tested
• Low insolubles
• Endotoxin tested
• Lot sizes from 250 kgs up to 24,000 kgs
• No detectable enzymes
• Package configuration for salts: 1 kg, 10 kg, 25 kg HDPE
• Low heavy metal content
• Package configuration for solutions: 200 L HDPE drums
• NIST traceable
• Mathematical uncertainty principles and error budgets are used to ensure accuracy • Custom concentrations available upon request
cGMP-MANUFACTURED pH BUFFER STANDARDS Product
Product Number
Product
Product Number
Product
Product Number
Grade
• Manufactured with multi-compendial grade pellets and validated USP Purified water
• Standard solutions from 0.5 N to 50%
• Lot sizes up to 6000 L
• Custom concentrations available upon request
• Package sizes: 4 L, 19 L, 200 L, 1000 L HDPE
Product
Product Number
Sodium Hydroxide, 0.5N
7668GMP
Sodium Hydroxide, 1.0N
7670GMP
Sodium Hydroxide, 5.0N
7672GMP
pH 0.50
974292GMP
pH 8.00
974392GMP
Ammonium Sulfate, NF
3514GMP
PharmaPUR
®
pH 1.68
974092GMP
pH 10.00
973692GMP
Guanidine Hydrochloride
3108GMP
PharmaPUR
®
pH 2.00
975392GMP
pH 12.47
973792GMP
HEPES
2200GMP
PharmaPUR
Sodium Hydroxide, 10.0N
7674GMP
pH 2.50
975192GMP
pH 13.00
974192GMP
MES, Monohydrate
2112GMP
PharmaPUR
Sodium Hydroxide, 25%
7676GMP
pH 3.00
973992GMP
974992GMP
MOPS
2212GMP
PharmaPUR
Sodium Hydroxide, 50%
7678GMP
pH 4.00
974592GMP
TRIS (Tromethamine), USP, EP
4010GMP
MultiPUR (USP, EP)
pH 6.00
974492GMP
TRIS Hydrochloride
4012GMP
PharmaPUR®
pH 6.68
974692GMP
Urea, USP, EP
8650GMP
MultiPUR® (USP, EP)
pH 7.00
973592GMP
Ammonium Sulfate 38% Solution
3540GMP
PharmaPUR®
• Lot sizes up to 3400 liters
Guanidine Hydrochloride 6M Solution
3110GMP
PharmaPUR®
• Manufactured with compendial grade acid and validated USP Purified water
pH 4.0 Red pH 7.0 Yellow
974792GMP
pH 10.0 Blue
974892GMP
All pH Buffers are supplied in cases of 6 x 500 ml HDPE Bottles.
® ® ®
®
PharmaPUR® Acid Dilutions • Packaging options: 6 x 500 ml HDPE Bottle, 4 x 4 L HDPE Bottle, 19 HDPE Pail, 200 L HDPE Drum, 1000 L HDPE Tote
• Custom concentrations available upon request cGMP-MANUFACTURED CONDUCTIVITY STANDARDS Product
Product Number
Product
Product Number
10 µS/cm
900192GMP
12,856 µS/cm
901092GMP
20 µS/cm
900692GMP
20,000 µS/cm
901192GMP
75 µS/cm
900792GMP
30,000 µS/cm
901292GMP
100 µS/cm
900292GMP
40,000 µS/cm
901392GMP
200 µS/cm
902092GMP
50,000 µS/cm
901492GMP
250 µS/cm
900892GMP
58,650 µS/cm
901692GMP
500 µS/cm
901992GMP
70,000 µS/cm
901792GMP
1000 µS/cm
900392GMP
100,000 µS/cm
901892GMP
2000 µS/cm
900992GMP
175,000 µS/cm
900592GMP
10,000 µS/cm
900492GMP
200,000 µS/cm
902292GMP
All Conductivity Standards are supplied in cases of 6 x 500 ml PET (Polyethylene terephthalate) Bottles.
MultiPUR Compendial Acids ®
• Packaging Options: 6 x 2.5 L HDPE Bottle, 4 x 4 L HDPE Bottle, 200 L HDPE Drum Product
Product Number
Concentration
Acetic Acid, Glacial, USP/EP/JP
2518GMP
99.5-100.5%
Hydrochloric Acid, NF/EP/JP
2632GMP
36.5-38.0%
Phosphoric Acid, NF/EP
2787GMP
85.0-88.0%
MultiPUR® Salts • Multi-compendial • Endotoxin tested • Package sizes: 1 kg, 10 kg, 25 kg HDPE
Product • Available in all one lot • Unit dose and bulk packaging available • Easy second source qualification
Product Number
Product
Acetic Acid Solutions 0.1 N
2499GMP
1.0 M
2500GMP
Product Number
Nitric Acid Solutions 1%
2734GMP
Phosphoric Acid Solutions
Product
Product Number
Quality Designation
4.0 N
2520GMP
33%
2806GMP
Sodium Chloride
8010GMP
USP, EP, JP
50%
2524GMP
75%
2786GMP
Sodium Hydroxide
7713GMP
NF, EP, JP
80%
2519GMP
Sodium Citrate, Dihydrate
8243GMP
USP, EP, JP
Sodium Phosphate, Monobasic Monohydrate
TBD
USP, EP1, JPE2
1.0 N
2894GMP
10%
5049GMP
Sodium Phosphate, Dibasic Heptahydrate
TBD
USP, EP3, JP4
2.0 N
8382GMP
50%
5039GMP
Sodium Acetate, Trihydrate
8012GMP
USP, EP, JP
4.5 N
2830GMP
Citric Acid, Monohydrate
8552GMP
USP, EP, JP
5.0 N
8386GMP
10.0 N
8388GMP
European Pharmacopeia requirements were determined by testing the material to the chemical specifications for Sodium Dihydrogen Phosphate, Dihydrate. 2Japanese Pharmacopeia Excipients (JPE) requirements were determined by testing the material to the chemical specifications for Sodium Dihydrogen Phosphate, Dihydrate. 3The European Pharmacopeia requirements were determined by testing the material to the chemical specifications for Disodium Phosphate Dihydrate and Disodium Phosphate Dodecahydrate. 4Japanese Pharmacopeia requirements were determined by testing the material to the chemical specifications for Dibasic Sodium Phosphate Hydrate.
Citric Acid Solutions
Hydrochloric Acid Solutions 0.1 N
6377GMP
0.5 N
6380GMP
1.0 N
6384GMP
2.0 N
6396GMP
3.0 N
6374GMP
6.0 N
6372GMP
15%
6376GMP
1
Sulfuric Acid Solutions
“Puritan has a unique willingness to help find solutions. Some suppliers just say no. Puritan always says ‘let’s see’ first.”