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Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

97583-08-9Doxycycline EP Impurity D

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Catalogue No.:	VL159003
CAS No.:	97583-08-9
Mol. Formula:	C22H24N2O8
Mol. Weight:	444.43 g/mol

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Additional information on CAS 97583-08-9

Parent drug

Doxycycline

IUPAC Name

(4R, 4aR, 5S, 5aR, 6S, 12aS)-4-(Dimethylamino)-3, 5, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-1, 4, 4a, 5, 5a, 6, 11, 12a-octahydrotetracene-2-carboxamide

Pharmacopoeial Synonyms

4-Epi 6-Epi Doxycycline

Other Synonyms

N/A

Smile

O=C(C1=C(O)[C@H](N(C)C)[C@@]([C@@H](O)[C@@]2([H])C(C(C3=C(O)C=CC=C3[C@H]2C)=O)=C4O)([H])[C@@]4(O)C1=O)N

InChI

InChI=1S/C22H24N2O8/c1-7-8-5-4-6-9(25)11(8)16(26)12-10(7)17(27)14-15(24(2)3)18(28)13(21(23)31)20(30)22(14,32)19(12)29/h4-7,10,14-15,17,25,27-29,32H,1-3H3,(H2,23,31)/t7-,10-,14-,15-,17+,22+/m1/s1

Characterization Data (Included)

HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, and Structure Elucidation Report (SER).

Additional Characterization Data

QNMR, D2O Exchange, 13C NMR, 13C APT, COSY NMR, NOESY NMR, 15N NMR, HSQC NMR, HMQC NMR, and HMBC NMR. These are available upon request and may be free or subject to additional charges.

Description

Doxycycline EP Impurity D also known as 4-Epi 6-Epi Doxycycline, in various pharmacopoeias, is a highly characterized standard. It meets strict regulatory requirements set by USP, EMA, JP, and BP, making it a crucial component in Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and the commercial production of Doxycycline. To ensure precision and reliability in analytical applications, this impurity standard is supplied with a detailed Structure Elucidation Report (SER), offering valuable insights for method development and quality control. Also known as Doxycycline EP Impurity D or 4-Epi 6-Epi Doxycycline, it is from second generation Tetracycline class of antibiotics. It is a synthetic derivative of oxytetracycline. Its absorption decreases with the antacids.

References

‘Smith, Kelly, and James J. Leyden. “Safety of Doxycycline and Minocycline: A Systematic Review.” Clinical Therapeutics, vol. 27, no. 9, Sept. 2005, pp. 1329–42, https://doi.org/10.1016/j.clinthera.2005.09.005. Saivin, S., and G. Houin. “Clinical Pharmacokinetics of Doxycycline and Minocycline.” Clinical Pharmacokinetics, vol. 15, no. 6, Dec. 1988, pp. 355–66, https://doi.org/10.2165/00003088-198815060-00001.