El anlisis en el control

de materias primas
Agua

Agua (H2O)

Normatividad mexicana (NOM, FEUM)

Tipos de agua

Agua potable
Agua purificada
Agua purificada estril
Agua para la fabricacin de
inyectables
Agua estril para uso inyectable
Agua bacteriosttica estril para
uso inyectable
Agua estril para irrigacin
Agua estril para inhalacin

Agua potable

Agua para uso y consumo humano,

agua que no contiene contaminantes
objetables, ya sean qumicos o
agentes infecciosos y que no causa
efectos nocivos para la salud.
Tambin se denomina como agua
potable.

Debe cumplir con la NOM-127-SSA11994 mod. 1999.

Puede provenir de fuentes diversas.

Agua purificada
vase Monografa FEUM
Se usa como ingrediente en la
fabricacin de productos farmacuticos
no inyectables, en la limpieza de algunos
equipos y en las fases finales de sntesis
de principios activos.
Se prepara a partir del agua potable
sometindola a procesos combinados
de
desionizacin,
ablandamiento,
descloracin y/o filtracin.
La destilacin o el proceso de smosis
inversa en la etapa final, aunque mas
costosos son ms adecuados.

 Anlisis por equipo de las

monografas de los diferentes
tipos de agua y elaboracin de un
cuadro comparativo de los
anlisis que se efectan

Material de Apoyo

Water R
Purified water as defined in the monograph for Purified water.
Note: Unless otherwise specified, all solutions indicated in the tests and
assays of The International Pharmacopoeia are prepared with water R.
Water, ammonia-free, R
Water that complies with the following additional test: to 50 ml add 2 ml of
alkaline potassio-mercuric iodide TS; no colour is produced.
Water, carbon-dioxide-free and ammonia-free, R
Ammonia-free water R that has been treated as described under carbondioxide-free water R.
Water, carbon-dioxide-free, R
Water that has been boiled vigorously for a few minutes and protected from
the atmosphere during cooling and storage.
Water for injections R
Water for injections as described in the monograph for Water for injections.
Water BET
Water is suitable if it gives a negative result under the conditions prescribed
in 3.4 Test for bacterial endotoxins. It may be prepared by distilling water
three times in an apparatus fitted with an effective device to prevent the
entrainment of droplets, or by other means which give water of the
requisite quality.
Water, particle-free R
Water R that has been filtered through a membrane with a pore size of 0.22
m.
Water, sterile, R
Sterile water R that complies with the following additional test:
Pyrogens. Carry out the test as described under 3.5 Test for pyrogens
injecting, per kg of the rabbit's weight, 10 ml of water that has been
rendered isotonic by the addition of pyrogen-free sodium chloride R.