cGMP Products

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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.”