MONOGRAFI

1. Ramipril

C23H32N2O5
Cyclopenta[b]pyrrole-2-carboxylic

416,51
acid,

1-[2-[[1-

(ethoxycarbonyl)-3-

phenylpropyl]amino]-1 oxopropyl]octahydro-, [2S-[1[R*(R*)],2a,3ab,6ab]]-;

(2S,3aS,6aS)-1-[(S)-N-[(S)-1-Carboxy-3- carboxylic acid, 1-ethyl ester [87333-19-5].
Ramipril contains NLT 98.0% and NMT 102.0% of C23H32N2O5, calculated on the
dried basis.
Packaging and storage preserve in tight containers.
Identification, infrared absorption.
Melting range; between 105o and 112o
Test solution: 10 mg per mL, in 0.1 M methanolic hydrochloric acid
Loss on drying dry it in vacuum at pressure not exceeding 5 mm of mercury at 60 o for
6 hours: it loses not more than 0.2% of its weight.
2. Microcrystalline Cellulose
BP: Dispersible Cellulose
PhEur: Microcrystalline Cellulose and Carmellose Sodium
USP-NF: Microcrystalline Cellulose and CarboxymethylcelluloseSodium
Synonyms: Avicel CL-611; Avicel RC-501; Avicel RC-581; Avicel RC-591; Avicel
RC/CL; cellulosum microcristallinum et carmellosum; natricum; colloidal cellulose;
Vivapur MCG 591 PCG; Vivapur; MCG 611 PCG.
Functional category; Dispersing agent; emulsion stabilizer; stabilizing agent;
suspending
agent; thickening agent.
Acidity/alkalinity pH 68 for a 1.2% w/v aqueous dispersion.
Density (bulk) 0.6 g/cm3
Microbial content Total aerobic microbial count 4100 cfu/g for Avicel RC/CL
(Escherichia coli, Staphylococcus aureus, Pseudomonasaeruginosa and Salmonella
species absent); total yeast and mold count 420 cfu/g for Avicel RC/CL.
Moisture content Not more than 6.0% w/w
Solubility Practically insoluble in dilute acids and organic solvents. Partially soluble in
dilute alkali and water (carboxymethylcellulose sodium fraction).

Stability and Storage Condition Microcrystalline cellulose and carboxymethylcellulose

sodium is hygroscopic and should not be exposed to moisture. It is stable over a pH range
of 3.511. Store in a cool, dry place. Avoid exposure to excessive heat.
Incompabilities Microcrystalline cellulose and carboxymethylcellulose sodium is
incompatible with strong oxidizing agents
3. Mannitol
Synonyms Cordycepic acid; C*PharmMannidex; E421; Emprove; manna sugar; Dmannite; mannite; mannitolum; Mannogem; Pearlitol.
D-Mannitol [69-65-8]
C6H14O6

182.17

Functional Category Diluent; plasticizer; sweetening agent; tablet and capsule diluent;
therapeutic agent; tonicity agent.
Density (bulk) 0.430 g/cm3 for powder; 0.7 g/cm3 for granules.
Density (tapped) 0.734 g/cm3 for powder; 0.8 g/cm3 for granules.
Density (true) 1.514 g/cm3
Dissociation constant pKa = 13.5 at 188C
Flash point <1508C
Flowability Powder is cohesive, granules are free flowing.
Heat of combustion 16.57 kJ/g (3.96 kcal/g)
Heat of solution _120.9 J/g (_28.9 cal/g) at 258C
Melting point 166168oC
Solubility

4. Sodium Starch Glycolate

Sodium carboxymethyl starch [9063-38-1]

Functional category tablet and capsule disintegrant

Melting point Does not melt, but chars at approximately 200oC.

Stability and Storage Condition Tablets prepared with sodium starch glycolate have
good storage properties.(2224) Sodium starch glycolate is stable although very
hygroscopic, and should be stored in a well-closed container in order to protect it from
wide variations of humidity and temperature, which may cause caking. The physical
properties of sodium starch glycolate remain unchanged for up to 3 years if it is stored at
moderate temperatures and humidity.
Incompabilities Sodium starch glycolate is incompatible with ascorbic acid.
5. Talcum
Talc [14807-96-6]
Mg6(Si2O5)4(OH)4
Acidity/alkalinity pH = 710 for a 20% w/v aqueous dispersion.
Hardness (Mohs) 1.01.5
Moisture content Talc absorbs insignificant amounts of water at 25 oC and relative
humidities up to about 90%.
Solubility Practically insoluble in dilute acids and alkalis, organic solvents, and water.
Stability and Storage Conditions Talc is a stable material and may be sterilized by
heating at 160oC for not less than 1 hour. It may also be sterilized by exposure to ethylene
oxide or gamma irradiation. Talc should be stored in a well-closed container in a cool, dry
place.
Incompabilities Incompatible with quaternary ammonium compounds.
6. Magnesium Stearate
[CH3(CH2)16COO]2Mg
Octadecanoic acid magnesium salt [557-04-0]
C36H70MgO4
591.24
Crystalline forms High-purity magnesium stearate has been isolated as a trihydrate, a
dihydrate, and an anhydrate.
Melting range 117150oC
Solubility Practically insoluble in ethanol, ethanol (95%), ether and water; slightly
soluble in warm benzene and warm ethanol (95%).
Stability and Storage Conditions Magnesium stearate is stable and should be stored in a
well-closed container in a cool, dry place.
7. Colloidal Silicone Dioxide (Aerosil)
Silica
SiO2
60.08
Acidity/alkalinity pH = 3.84.2 (4% w/v aqueous dispersion) and 3.54.0 (10% w/v
aqueous dispersion) for Cab-O-Sil M-5P
Melting point 1600oC

Solubility Practically insoluble in organic solvents, water, and acids, except hydrofluoric
acid; soluble in hot solutions of alkali hydroxide. Forms a colloidal dispersion with water.
For Aerosil, solubility in water is 150 mg/L at 25oC (pH 7).
Stability and Storage Conditions Colloidal silicon dioxide is hygroscopic but adsorbs
large quantities of water without liquefying. When used in aqueous systems at a pH
07.5, colloidal silicon dioxide is effective in increasing the viscosity of a system.
However, at a pH greater than 7.5 the viscosity increasing properties of colloidal silicon
dioxide are reduced; and at a pH greater than 10.7 this ability is lost entirely since the
silicon dioxide dissolves to form silicates.(14) Colloidal silicon dioxide powder should be
stored in a well-closed container.
Incompabilities Incompatible with diethylstilbestrol preparations.
DAFTAR PUSTAKA
The United States Pharmacopeial Convention. 2004. The United States Pharmacopeia (USP)
29th edition. Rockville(MD): The United States Pharmacopeial Convention, vol. 31(3) page 787