Clase 1 AMDDA2015

La palabra Farmacopea procede

del griego y significa "cmo
hacer medicamentos".

Farmacopea:
Conjunto
de
especificaciones
(como monografas) que deben
satisfacer los medicamentos y sus
materias primas.

Farmacopea:

Texto oficial

Garantizar la fabricacin y circulacin

de medicamentos de buena calidad

Proteger la salud de los consumidores

Clase 1 AMDDA2015

Listado de Farmacopeas
(OMS)
www.who.int
INDEX OF PHARMACOPOEIAS

The United States Pharmacopeia

(USP)
General Notices and Requirements
USP Monographs
General Chapters

General Test and Assays <1>

General Information <1015>

Reagents
Reference Tables
Nutritional Supplements
NF Monographs

Clase 1 AMDDA2015

USP29

Sulfamethoxazole

C10H11N3O3S

253.28

Benzenesulfonamide, 4-amino-N-(5-methyl-3-isoxazolyl)-N1-(5-Methyl-3-isoxazolyl)sulfanilamide [723-46-6].

Sulfamethoxazole contains not less than 99.0 percent and not more than 101.0 percent of C10H11N3O3S,
calculated on the dried basis.
Packaging and storage Preserve in well-closed, light-resistant containers
USP Reference standards <11> USP Sulfamethoxazole RS. USP Sulfanilamide RS.
Identification
A: Infrared Absorption <197K>.
B: Ultraviolet Absorption <197U>
Solution: 10 g per mL.
Medium: sodium hydroxide solution (1 in 250).
Absorptivities at 257 nm, calculated on the dried basis, do not differ by more than 2.0%.
C: Dissolve about 100 mg in 2 mL of hydrochloric acid, and add 3 mL of sodium nitrite solution (1 in 100)
and 1 mL of sodium hydroxide solution (1 in 10) containing 10 mg of 2-naphthol: a red-orange precipitate
is formed.

Melting range, Class I <741> : between 168 and 172 .

Loss on drying <731> Dry it at 105 for 4 hours: it loses not more than 0.5% of its weight.
Residue on ignition <281> : not more than 0.1%.
Selenium <291> : 0.003%, a 200-mg test specimen being used.
Sulfanilamide and sulfanilic acid
Standard solution Dissolve 100 mg of USP Sulfamethoxazole RS in 0.10 mL of ammonium hydroxide,
dilute with methanol to 10.0 mL, and mix.
Reference solution Dissolve 20 mg of USP Sulfanilamide RS and 20 mg of sulfanilic acid in 10 mL of
ammonium hydroxide, and dilute with methanol to 100 mL. Transfer 2.0 mL of the solution to a 50-mL
volumetric flask, add 10 mL of ammonium hydroxide, dilute with methanol to volume, and mix.
Test solution Dissolve 100 mg in 0.10 mL of ammonium hydroxide, dilute with methanol to 10.0 mL, and
mix.
Procedure Apply 10 L of the Standard solution, 25 L of the Reference solution, and 10 L of the Test
solution to a suitable thin-layer chromatographic plate (see Chromatography <621> ) coated with a 0.25-mm
layer of chromatographic silica gel. Allow the spots to dry, and develop the chromatogram in a solvent system
consisting of a mixture of alcohol, n-heptane, chloroform, and glacial acetic acid (25:25:25:7) until the solvent
front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and allow
it to air-dry. Spray the plate with a solution prepared by dissolving 0.10 g of p-dimethylaminobenzaldehyde in

Clase 1 AMDDA2015

1 mL of hydrochloric acid and diluting with alcohol to 100 mL. Sulfamethoxazole produces a spot at about
RF 0.7, sulfanilamide at about RF 0.5, and sulfanilic acid at about RF 0.1. Any spots produced by
sulfanilamide or sulfanilic acid from the Test solution do not exceed in size or intensity similar spots,
occurring at the respective RF values, produced by sulfanilamide or sulfanilic acid from the Reference
preparation (0.2%).
Organic volatile impurities, Method IV <467> : meets the requirements.
Residual solvents <467> : meets the requirements.

Assay Dissolve about 500 mg of Sulfamethoxazole, accurately weighed, in a mixture of 20 mL of

glacial acetic acid and 40 mL of water, and add 15 mL of hydrochloric acid. Cool to 15 , and
immediately titrate with 0.1 M sodium nitrite VS, determining the endpoint potentiometrically using a
calomel-platinum electrode system. Each mL of 0.1 M sodium nitrite is equivalent to 25.33 mg of
C10H11N3O3S.

Anlisis de Medicamentos

Involucra conceptos de....

Qumica Orgnica
Carcter cido-base
Reactividad
Valores de pKa

Qumica Analtica
Metododologas:
Aplicabilidad
Intervalo de deteccin [c]
Interferentes

Clase 1 AMDDA2015

Ka

Ka

SULFANILAMIDA

6
pH

10,4

1
orina

14

pH

14

pH

pKa

SULFANILAMIDA

6
pH

10,4

1
orina

pKa

Clase 1 AMDDA2015

CH3

CH3

CH3

CH3

R
H 3
CH

CH 3

CIDO
BSICO

HO

ANFTERO

O
NEUTRO

OH

Clase 1 AMDDA2015

CH 3

CIDO
BSICO

HO

ANFTERO

O
NEUTRO

OH

CIDO
O

CH3
+

N
H3 C

CH3

CH3

BSICO
ANFTERO
NEUTRO

CIDO
BSICO
HN
O

N
H

ANFTERO
NEUTRO

Clase 1 AMDDA2015

CH3
N

CIDO
BSICO

CH2 OH

ANFTERO
NEUTRO

CIDO
BSICO
ANFTERO
NEUTRO

CIDO
BSICO
ANFTERO
NEUTRO