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11987DW PG_pharm_v7

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Pharmaceutical
Industry
Dow Propylene Glycol USP/EP (PG
USP/EP) is widely used in the pharmaceutical industry. PG USP/EP is approved
for use in many jurisdictions around the
world as a non-active excipient in pharmaceuticals. With a certified purity greater
than 99.8 percent by weight, it is used in
numerous pharmaceutical formulations.
• Toothpastes
Dow PG USP/EP offers excellent
functionality as a(n):
Product Snapshot
• Emollient for softening and smoothing
• Humectant for promoting moisture
retention in skin-care products
• Coupling agent
• Plasticizer in aqueous film coating
formulations
• Emulsion stabilizer
• Dispersant
• Viscosity modifier
PG USP/EP from Dow is also commonly
used as a key ingredient in numerous
types of cosmetic and personal care
formulations. These include products
such as:
• Shaving creams
• Antiperspirants and deodorants
• Moisturizers
• Ointments and creams
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An overview of typical uses of propylene
glycol in pharmaceutical formulations
is also published in the Handbook of
Pharmaceutical Excipients.2
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Dow PG USP/EP is a clear, colorless,
practically odorless, slightly viscous,
water-soluble and hygroscopic liquid
with low vapor pressure. It has a
product shelf life of two years when
stored below 104°F (40°C) in closed
containers protected from UV light.
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• Solvent and extractant for a wide
range of active ingredients, such as
corticosteroids, phenol derivatives,
barbiturates, vitamins (A and D),
most alkaloids and many local
anesthetics1 (refer to page 3 for
solubility of individual ingredients in
propylene glycol)
• Soaps and cleansing products
The U.S. Food and Drug
Administration (U.S. FDA) Inactive
Ingredient Guide1 lists various different
dosage forms, routes of administration
and maximum potency (concentration)
for propylene glycol in approved drug
products. This list includes, apart
from others, injections, oral, topical
and inhalation preparations with
varying PG concentration, exceeding
80 percent in some cases.
An Acceptable Daily Intake (ADI) of
0-25 mg/kg bodyweight has been
assigned for propylene glycol by the
Scientific Committee on Food of the
European Commission.3
Application Overview
Application Snapshot
Regulatory Status
Dow PG USP/EP is tested against and is certified to the specific requirements of the:
• United States Pharmacopeia (USP)
• European Pharmacopoeia (PhEur or EP)
• Japanese Pharmacopoeia (JP)
All requirements of these monographs are included on Dow’s Certificate of Analysis (CoA) for
PG USP/EP. For compendia items that are in statistical control and show limited analytical
variation, tests are carried out on a statistical, quarterly basis as noted on the CoA. Dow PG
USP/EP also meets the requirements and standards of the:
• U.S. Food and Drug Administration (U.S. FDA) – Due to its extremely low toxicity and long
history of safe use, PG USP/EP is generally recognized as safe (GRAS) by the U.S. FDA for
use in pharmaceuticals. Propylene glycol is included in the U.S. FDA Inactive Ingredient
Guide1 in a variety of different dosage forms and routes of administration.
• Food Chemicals Codex (FCC)
• Brazilian Pharmacopoeia (Farmacopéia Brasileira)
Dow PG USP/EP also complies with the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline
Q3C “Impurities: Guideline for Residual Solvents.”4 It is manufactured from hydrocarbon
raw materials in a solventless process and does not contain detectable quantities of class 1, 2
or 3 solvents as defined in this ICH guideline.
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Purity Plus
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Dow PG USP/EP’s certified purity of greater than 99.8 percent is maintained along the supply
chain by producing and handling this pharmaceutical excipient according to Good
Manufacturing Practices (GMP) principles, as issued by the International Pharmaceutical
Excipients Council (IPEC) and Pharmaceutical Quality Group (PQG).5
Dow’s customers’ need for purity and Dow’s dedication to
Good Manufacturing Practices (GMP) are the heart of
Dow’s Purity Plus standards. With Dow’s level of commitment to meeting numerous standards in PG USP/EP,
customers can be confident they receive a fully compliant
PG USP/EP product from Dow.
Dow’s commitment to GMP is based on the IPEC-PQG Good
Manufacturing Practices Guide for Pharmaceutical Excipients
(2006).5
Our commitment to implementing GMP through the manufacture, storage, packaging, transportation and distribution
of Dow PG USP/EP helps ensure that the product meets the
customers’ need for Purity. The Plus comes from Dow’s
proven ability to offer customers:
• Customer Support
– Global Technical Service & Development and
Quality Assurance groups
– Technical support for handling, storage and use of
Dow PG USP/EP
• Education and Training
– Detailed information and literature downloads at
www.dowpg.com
– Web-based distributor GMP training module
– Easy access to area Customer Information Groups
(see phone numbers on last page)
• Product Stewardship
– Strong commitment to Responsible Care®
– GMP-compliant processing and handling
throughout the supply chain
• Experience
– One of the world’s leading producers of propylene
glycol
– Nearly 60 years of propylene glycol manufacturing/
supply experience
• Commitment to Quality
– Detailed personnel training
– Continual investment in maintaining and upgrading
equipment
– Global distributor review, qualification and
training program
• Global, Reliable Supply
– Five strategically located manufacturing sites and
multiple terminals
– Annual global capacity exceeding 705 kilotons
Find additional information about Dow’s Purity Plus
standards in the document titled “Propylene Glycol
USP/EP from Dow, Purity Plus: Application of Good
Manufacturing Practices (GMP)” (Form No. 117-01636X).
Ingredient Solubility
Local Anesthetics
Benzocaine
Benzyl Alcohol
Diothane
Salicyl Alcohol (Saligenin)
% Solubility
Antiseptics
Camphor
Calcium Sulfocarbolate
Chlorothymol
Hexylesorcinol
Menthol
Merthiolate
Metaphen
Salol
Thymol
Trichloro-tert-butanol
Zinc Sulfocarbolate
9.80
> 30.00*
70.00
> 80.00*
> 50.00
> 29.00
< 0.27
10.50
> 50.00
> 60.00
> 39.00
Vitamins and Hormones
Estradiol (mg per cc)
Ascorbic Acid
Calcium Pantothenate
Nicotinic Acid
Pyridoxine Hydrochloride
Riboflavin
Thiamine Hydrochloride
Vitamin A (12% in oil)
0.50
8.16
2.04
0.88
2.73
< 0.006
5.14
insol.
Organic Substances
Acacia Gum
Calcium Glycerosphosphate
Cetyle Alcohol
Pectin
Phenothiazine (Purified)
Sodium Citrate
Tannic Acid
< 0.16
< 0.07
0.23
insol.
< 1.15
0.23
> 45.20
12.20
x
5.00
4.00
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55.70
9.40
6.00
0.30
7.25
0.50
1.71
18.20
22.20
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2.09
0.52
2.10
4.37
> 55.00
0.77
> 89.00
> 57.00
< 0.45
11.22
44.10
x
< 0.08
> 49.00
Material
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% Solubility
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Drugs and Medicinals
Acetanilide
Acetarsone
Acethophenitidine
Alion
Antipyrine
Caffeine
Chloral Hydrate
Ethyl Carbamate
Glycine
Hexamethylenetetramine
o-Hydroxybenzyl Alcohol
Paraldehyde
Pepsin
Phenobarbital
(Luminal Sodium)
Resorcinol
Sodium Bismuth Thioglycolate
Sodium Iodobismuthite
Sulfadiazine
Sulfanilamide
Sulfapyridine
Sulfathiazole
Terpin Hydrate
Urea
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Material
Inorganic Substances
Cupric Oxide
Ferric Oxide
insol.
insol.
*Viscosity of solutions prevented further additions of solid
> = greater than
insol. = not soluble
x = miscible or soluble in all proportions
< = less than
Literature References
1. Inactive Ingredient Guide, U.S. Food and Drug Administration, 2008 (http://www.fda.gov/cder/drug/iig/default.htm)
2. Handbook of Pharmaceutical Excipients, fourth edition, edited by Raymond C. Rowe, Paul J. Sheskey and Paul J. Weller, Pharmaceutical
Press and American Pharmaceutical Association, 2003
3. Report of the Scientific Committee on Food on Propylene Glycol (40th series), p63-64, Commission of the European Communities, 1997
(opinion expressed September 20, 1996) (http://ec.europe.eu/food/fs/sc/scf/reports/scf_reports_40.pdf)
4. Impurities: Guideline for Residual Solvents, ICH Guideline Q3C (R3)
5. IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients, International Pharmaceutical Excipients Council (IPEC)
and Pharmaceutical Quality Group (PQG), 2006
Asia Pacific
Dow Chemical Malaysia Sdn Bhd
Customer Information Group
Level 6, CP Tower, Section 16/11
Jalan Damansara
46350 Petaling Jaya
Selangor DE, Malaysia
Toll Free: +800 7776 7776
Toll: +60 3 7958 3392
Toll Free Fax: +800 7779 7779
Toll Fax: +60 3 7958 5598
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Toll Free: 800-447-4369
Toll: 989-832-1542
Fax: 989-832-1465
Europe, India, Middle East & Africa
Dow Belgium B.V.B.A.
Prins Boudewijnlaan 41
B-2650 Edegem
Belgium
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North America
Dow CIG North America
4520 E. Ashman St.
9008 Building
Midland, MI 48642
International Toll Free: +800 3 694 6367
Toll: +32 3 450 2240
Italy Toll Free: 800 783 825
South Africa Toll Free: +800 99 5078
Fax: +32 3 450 2815
Latin America
Dow Brazil S.A.
CIG-Latin/3C floor
Rua Alexandre Dumas, 1671
Chacara Santo Antonio
04717-903 São Paulo, Brazil
Toll: +55-11-5188-9000
Fax: +55-11-5188-9887
Material Safety Data Sheets (MSDS) and Technical
Data Sheets (TDS) available at www.dowpg.com
www.dowpg.com
NOTICE: Because use conditions and applicable laws may differ from one location to another and may change with time, the recipient
of this information is solely responsible for determining whether the information in this document is appropriate for recipient’s use.
Since Dow has no control over how this information may be ultimately used, all liability is expressly disclaimed and Dow assumes
no obligation or liability therefore. No warranty, express or implied, is given, nor is freedom from any patent owned by Dow or others
to be inferred.
®™Trademark of The Dow Chemical Company (“Dow”) or an affiliated company of Dow
®Responsible Care is a service mark of the American Chemistry Council in the United States
Form No. 117-01635X-0808P&M
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