1. OverView:
(1) Cyproterone acetate (INN, USAN, BAN, JAN; abbreviated as CPA, sold under brand names such as Androcur and Cyprostat) is a synthetic steroidal antiandrogen, progestin, and antigonadotropin.
(2) Cyproterone acetate is primarily used in the treatment of androgen-related conditions by virtue of its ability to suppress androgenic activity in the body, an effect which it mediates by preventing endogenous androgens from interacting with the androgen receptor and by suppressing androgenbiosynthesis. CPA is also used for its progestogenic effects, for instance, as a component of some combined oral contraceptive pills, such as in Dianette in the United Kingdom, Diane-35 in Canada, Bella Hexal in Germany, Diane in Sweden, and Dixi-35 in Chile.
2. Applications:
(1) CPA has been in use as an antiandrogen since 1964, and was the first antiandrogen introduced for clinical use. It is widely used throughout Europe, and is also used in Canada, Mexico, and other countries. It is not FDA-approved for use in the United States, due to concerns about hepatotoxicity; medroxyprogesterone acetate has been used in this country instead. CPA has been approved for the treatment of prostate cancer, precocious puberty, androgen-related dermatological conditions (such as acne, seborrhea, hirsutism, and androgenic alopecia), and to reduce sex drive in sex offenders.Combination formulations of CPA with ethinyl estradiol (a formulation sometimes referred to as co-cyprindiol) have been available as contraceptives since 1997.
(2) Other uses of CPA include the treatment of benign prostatic hyperplasia, priapism, hypersexuality, paraphilias, hot flashes, and hyperandrogenism in women. In addition, with the exception of the United States (where CPA is not available and spironolactone is generally employed instead), CPA is widely used as a component of hormone replacement therapy fortrans women.
3. How to use it:
(1) Cyproterone acetate will only prevent a pregnancy if it is taken properly. It is important you take this medicine regularly at the same time each day. If you want immediate contraceptive cover then start to take Cyproterone acetate on the first day of your menstrual period.
(2) Once you have started to take Cyproterone acetate, you should take it once a day for 21 days. After this you should not take any more tablets for the next seven days. Start a new strip of Cyproterone acetate immediately after the seven day tablet-free break. During this break you will usually have a withdrawal bleed. If you do not have a withdrawal bleed during the tablet-free break and you have taken all your pills properly, you are very unlikely to be pregnant. However, you should immediately contact your prescriber or family planning nurse if you have not taken your pills properly. This is because there is a possibility that you could be pregnant and you must not take Cyproterone acetate during pregnancy.
In certain situations the effectiveness of Cyproterone acetate may be reduced and you will need to take extra contraceptive precautions. These situations include: missing a dose by more than 12 hours; taking other medicines that interact with Cyproterone acetate; or having diarrhoea or vomiting. If any of these situations occur during the last seven days of your tablet strip you should not have a tablet-free break between strips of tablets. Start taking the next strip of tablets without a break.
(3) As there is no gap between strips you will not have a withdrawal bleed at the end of the first strip. But you may have some menstrual bleeding while you are taking the second strip and you should have a withdrawal bleed once you finish the second strip.
4. COA:
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Analysis Test
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Specification
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Result
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Description
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white crystalline powder,odorless
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Conforms
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Solubility
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Easily soluble in water, unsoluble in ethanol
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Conforms
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PH
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6.0~7.5
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6.9
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Solution clarity and color
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solution should be clear and colorless
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Conforms
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Related substances
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5’CMP 0.3%
Simple impurity
Total other impurity
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0.01%
0.03%
0.10%
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Chloride
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0.05%
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Conforms
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Ammonium
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0.05%
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Conforms
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Fe
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0.01%
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Conforms
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Phosphate
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0.1%
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Conforms
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Loss on drying
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≤6.0%
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1.3%
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Heavy metals
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0.002%
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Conforms
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Arsenide
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0.0001%
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Conforms
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Bacterial Endotoxins
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0.3EU/mg
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Conforms
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Microbial Limit
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Conforms
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Conforms
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Assay(on dried basis)
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≥98.0%
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98.8%
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Conclusion: The results conform with CP2010
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