Supersedes issue dated February 2009
03_030752e-06/Page 1 of 6
USP, Ph. Eur.
1. Medical indication
Tretinoin is a synthetic vitamin A acid derivative used for the treatment of severe
forms of acne, such as acne conglobata and acne cystica, which are mostly resistant
to other forms of treatment. Tretinoin is a stereoisomer of Isotretinoin.
Formulations for the treatment of acne are mostly creams, gels or solutions. Fur-
thermore, there is also an oral formulation marketed for the treatment of special
A teratogenic effect in humans, as known for Isotretinoin, has not been reported
in published papers. However, there are publications reporting a teratogenic ef ect
in animals. Therefore, precautions must be taken if Tretinoin is to be used by women:
Contraceptive measures should be used starting one month before and ending
one month after treatment with Tretinoin. Tretinoin must not be administered during
pregnancy. All formulations of Tretinoin are prescription drugs.
Tretinoin reduces the production of sebum in the skin and the size of the
Absorption rates in topical application vary greatly, ranging between 0.5% and
25%, depending on the formulation and quantity applied on the skin. No detailed
data on Tretinoin’s kinetic profile is available.
2. Chemical information
All-trans-vitamin A acid, all-trans-retinoic acid, all-A vitamin acid
See separate documentation: “Q&R PI (not for regulatory purposes)” available at
BASF’s WorldAccount: https://worldaccount.basf.com (registered access).
4. Physical and chemical properties
Yellow to yellowish-orange crystalline powder
5. Regulatory status
Meets current USP and Ph. Eur. monographs.
The open part of the DMF is available.
6. Safety aspects
Published papers suggest a high teratogenic potential of Tretinoin in animals.
“It is unlawful to sell or offer for sale dangerous substance without indicating the
dangers relating to the substance in accordance with § 3 a, Section 1.”
See separate document: “Standard Specification (not for regulatory purposes)”
available via BASF‘s WorldAccount: https://worldaccount.basf.com (registered
8. Storage conditions
Store in air-tight containers below 25 °C and protected from air and light.
Containers that have been opened must be kept under nitrogen or argon and
should be used up as quickly as possible. Once opened, containers must be
9. Particle characterization
The particle size is measured by laser light dif ractometry in an aqueous suspension.
Typical values of particle size distribution:D 0.1
10. General information
Only peroxide-free pharmaceutical excipients should be used for the formulation.
on the processing of
Ingredients that tend to form peroxides should be strictly avoided.
Butylhydroxytoluene is recommended as an antioxidant.
Opened packages should be flushed with nitrogen or argon, tightly closed again
11. Formulating examples
Tretinoin Cream (50 mg/100 g)
Separately prepare solution I and mixture II by heating to about 75 °C.
Heat mixture III until a clear solution is formed.
Add solution I to the warm mixture II, then add mixture III and cool by stirring.
3. Chemical stability (20 – 25 °C, dark)
Analytical method: Spectrophotometric at 358 nm in chloroform +
Tretinoin Gel (50 mg/100 g)
Prepare suspension II and add solution III to the well-stirred suspension.
When a clear mixture is formed, add solution I.
Tretinoin + Dexpanthenol Gel (50 mg + 2,500 mg/100 g)
Add I slowly to the clear solution I at about 40 °C. Heat to about 50 °C and dissolve
about 4 g of I I in I/I . Cool to about 6 °C and dissolve the rest of I I. Keep cool until
4. Chemical stability (12 months, 23 °C, dark)
It is important to protect the gel from light to prevent the isomerization and degradation
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constitute a legal y binding obligation of BASF. While the descriptions, designs, data
and information contained herein are presented in good faith and believed to be
accurate, it is provided for your guidance only. Because many factors may affect
processing or application/use, we recommend that you make tests to determine
the suitability of a product for your particular purpose prior to use. It does not relieve
our customers from the obligation to perform a ful inspection of the products upon
delivery or any other obligation. NO WARRANTIES OF ANY KIND, EITHER EXPRESS
OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS DESCRIBED
OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE PRODUCTS,
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- Care Chemicals Division - Pharma Ingredients & Services - 67117 Limburgerhof - www.pharma-ingredients.basf.com
Title 29: Labor PART 570—CHILD LABOR REGULATIONS, ORDERS AND STATEMENTS OF INTERPRETATION Subpart E—Occupations Particularly Hazardous for the Employment of Minors Between 16 and 18 Years of Age or Detrimental to Their Health or Well-Being Authority: 29 U.S.C. 203(l), 212, 213(c). Note: The provisions of this subpart declaring certain occupations to be particularly hazardous f
I. INTRODUCTION The named End-Payor plaintiffs seek class certification of a class comprised of individual consumers, third-party payors (“TPPs”), union plan sponsors, and insurance companies that purchased or provided reimbursements for Nexium in those states that permit such an action. See Corrected Consol. Am. Class Action Compl. & Demand Jury Trial (“End-Payors’ Compl.”)