Monographs
Monograph of Sodium Chloride
1. Chemical Information
• Official Name: Sodium Chloride
• Molecular Formula: NaCl
• Molecular Weight: 58.44 g/mol
• CAS Number: 7647-14-5
2. Description
• White, crystalline powder or colorless crystals.
• Odorless, with a characteristic saline taste.
• Freely soluble in water, practically insoluble in alcohol.
3. Identification (IP Standards)
1. Appearance of Solution: A 10% solution should be clear and colorless.
2. Solubility Test: Freely soluble in water.
3. Chemical Test:
• A solution of sodium chloride gives a white precipitate with silver
nitrate (AgNO₃), which is soluble in ammonium hydroxide (NH₄OH).
4. pH
• A 5% w/v solution in water should have a pH between 4.5 and 7.0.
5. Assay (Purity Test)
• Sodium chloride content should be 99.0% to 100.5% on a dried basis.
6. Impurities & Limits
• Loss on Drying: Not more than 0.5% (determined at 105°C for 2 hours).
• Insoluble Matter: Not more than 0.01%.
• Acidity or Alkalinity: A 10% solution should remain neutral or slightly
acidic/basic.
• Heavy Metals (as Pb): Not more than 5 ppm.
• Sulfates (SO₄²⁻): Not more than 0.002%.
• Iron (Fe): Not more than 2 ppm.
• Magnesium & Alkaline Earth Metals (as Ca): Not more than 0.02%.
• Bromides (Br⁻): Not more than 0.01%.
7. Storage & Packaging
• Store in a well-closed container to protect from moisture.
• Keep in a cool, dry place away from contaminants.
8. Uses (As per IP Standards)
• Used in the preparation of parenteral solutions (IV fluids).
• Commonly used in oral rehydration salts (ORS).
• Acts as a pharmaceutical excipient in drug formulations.
• Used as a saline laxative in medical treatments.
Monograph of Calcium Gluconate
1. Chemical Information
• Official Name: Calcium Gluconate
• Molecular Formula: C₁₂H₂₂CaO₁₄
• Molecular Weight: 430.37 g/mol
• CAS Number: 299-28-5
• Chemical Structure: Calcium salt of gluconic acid
2. Description
• White or almost white, crystalline or granular powder.
• Odorless and tasteless.
• Freely soluble in boiling water, sparingly soluble in cold water, and
practically insoluble in alcohol.
3. Identification (IP Standards)
1. Solubility Test:
• Sparingly soluble in cold water, freely soluble in boiling water.
2. Chemical Tests:
• Calcium Test: When treated with ammonium oxalate, a white precipitate
of calcium oxalate (CaC₂O₄) forms.
• Gluconate Test: Positive reaction with Fehling’s solution, indicating
the presence of gluconate.
4. pH
• A 10% w/v aqueous solution should have a pH between 6.0 and 8.0.
5. Assay (Purity Test)
• Calcium gluconate content should be 98.0% to 102.0% on a dried basis.
6. Impurities & Limits
• Loss on Drying: Not more than 3.0% (at 105°C for 2 hours).
• Heavy Metals (as Pb): Not more than 20 ppm.
• Chlorides (Cl⁻): Not more than 0.05%.
• Sulphates (SO₄²⁻): Not more than 0.05%.
• Reducing Sugars: Should pass the prescribed test.
• Arsenic (As): Not more than 2 ppm.
7. Storage & Packaging
• Store in a well-closed container to prevent moisture absorption.
• Protect from light and excessive heat.
8. Uses (As per IP Standards)
• Used as a calcium supplement in the treatment of calcium deficiency.
• Administered in hypocalcemia, osteoporosis, and neonatal tetany.
• Used in parenteral and oral pharmaceutical formulations.
• Acts as an antidote in magnesium sulfate poisoning.
Monograph of Ammonium Chloride
1. Chemical Information
• Official Name: Ammonium Chloride
• Molecular Formula: NH₄Cl
• Molecular Weight: 53.49 g/mol
• CAS Number: 12125-02-9
• Chemical Structure: Ionic compound of ammonium (NH₄⁺) and chloride
(Cl⁻).
2. Description
• White, crystalline powder or colorless crystals.
• Odorless, with a cooling, saline taste.
• Soluble in water, slightly soluble in alcohol, and insoluble in ether.
• The aqueous solution is mildly acidic.
3. Identification (IP Standards)
1. Solubility Test: Freely soluble in water, slightly soluble in alcohol.
2. Chemical Tests:
• Chloride Test: Produces a white precipitate with silver nitrate (AgNO₃)
in the presence of nitric acid (HNO₃), confirming the presence of chloride ions.
• Ammonium Test: When heated with sodium hydroxide (NaOH), it releases
ammonia (NH₃), which turns moist red litmus paper blue.
4. pH
• A 5% w/v aqueous solution should have a pH between 4.5 and 6.0.
5. Assay (Purity Test)
• Ammonium chloride content should be 99.0% to 100.5% on a dried basis.
6. Impurities & Limits
• Loss on Drying: Not more than 1.0% (at 105°C for 2 hours).
• Sulphates (SO₄²⁻): Not more than 0.02%.
• Heavy Metals (as Pb): Not more than 10 ppm.
• Iron (Fe): Not more than 10 ppm.
• Residue on Ignition: Not more than 0.1%.
7. Storage & Packaging
• Store in a well-closed container in a cool, dry place.
• Protect from moisture and heat.
8. Uses (As per IP Standards)
• Used as an expectorant in cough syrups and respiratory medicines.
• Acts as a systemic acidifier in treating metabolic alkalosis.
• Utilized in intravenous fluids and electrolyte replacement therapy.
• Used in veterinary medicine, fertilizers, and industrial applications.
Monograph of Hydrogen Peroxide
1. Chemical Information
• Official Name: Hydrogen Peroxide
• Chemical Formula: H₂O₂
• Molecular Weight: 34.01 g/mol
• CAS Number: 7722-84-1
2. Description
• A clear, colorless, slightly viscous liquid.
• Possesses a characteristic pungent odor.
• Commonly available as an aqueous solution (e.g., 3%, 6%, 35%), often
stabilized with acids to retard decomposition.
3. Identification (IP Standards)
• Chemical Reaction Test:
• When an aliquot of the hydrogen peroxide solution is acidified and
treated with an excess of potassium iodide (KI), the liberated iodine imparts a
characteristic color that is confirmed by subsequent titration with sodium
thiosulfate.
• This reaction verifies the oxidizing nature of hydrogen peroxide and
confirms its identity.
4. Assay (Purity Test)
• Iodometric Titration:
• An aliquot of the hydrogen peroxide solution is titrated with a
standard solution of sodium thiosulfate in the presence of starch as an indicator.
• The assay is expressed in terms of “active oxygen” and should be not
less than the labeled claim (typically not less than 90% of the stated content).
5. Impurities & Limits
• Extraneous Matter: The solution should be free from particulate or
insoluble matter.
• Heavy Metals: The content of heavy metals (e.g., lead) should not
exceed the prescribed limits (e.g., not more than 5–10 ppm, as applicable).
• Stabilizers: Any stabilizers present (if declared) must be within the
specified limits to ensure product stability and purity.
Note: The specific limits for heavy metals and other impurities are as per the
detailed IP requirements applicable to the particular concentration and intended
use of the hydrogen peroxide solution.
6. Storage & Packaging
• Storage Conditions:
• Store in a cool, well-ventilated area away from direct sunlight and
heat.
• Keep in tightly closed, light-resistant (e.g., amber) containers to
minimize decomposition.
• Packaging:
• The container material should be compatible with hydrogen peroxide
(typically glass or high-density polyethylene).
7. Uses (As per IP Standards)
• Widely used as a disinfectant and antiseptic in pharmaceutical
preparations.
• Employed in various sterilization and bleaching processes.
• Utilized in water treatment, chemical synthesis, and other industrial
applications where an oxidizing agent is required.
Monograph of Chlorinated Lime
1. Chemical Information
• Official Name: Chlorinated Lime
• Description: Chlorinated Lime is prepared by treating slaked lime
(calcium hydroxide) with chlorine. It is characterized by its available chlorine
content and is used primarily as a disinfectant and bleaching agent.
• Nature: It is not a single chemical entity but a preparation containing
active chlorine compounds (predominantly calcium hypochlorite along with minor
chlorinated species).
2. Description
• A white or slightly off-white powder or granular solid.
• Possesses a characteristic pungent odor of chlorine.
• Exhibits a strong oxidizing property due to its available chlorine.
• When in contact with moisture, it may release chlorine gas.
3. Identification (IP Standards)
• Chlorine Test:
• When a weighed sample is dissolved in water and acidified, the
liberated chlorine reacts with an excess of potassium iodide (KI) to release
iodine.
• The liberated iodine is then titrated with a standard sodium
thiosulfate solution using starch as an indicator.
• The appearance of a blue starch–iodine complex, which is subsequently
decolorized on titration, confirms the presence of available chlorine.
• Physical Appearance:
• The material should conform to the described physical characteristics
(color, odor, and texture).
4. Assay (Determination of Available Chlorine)
• Method: Iodometric Titration
• A precisely weighed sample is dissolved in water under controlled
conditions.
• The solution is acidified and treated with excess KI, liberating iodine
equivalent to the available chlorine content.
• The iodine liberated is titrated with a standardized sodium thiosulfate
solution until complete decolorization of the starch indicator occurs.
• Specification:
• The available chlorine content is expressed as a percentage of chlorine
and should not be less than the specified limit (commonly around 42% available
chlorine by weight, though the exact specification may vary with the intended use
and lot).
5. Impurities & Limits
• Loss on Drying:
• Should not exceed a specified limit (typically determined at 105°C for
a defined period, e.g., not more than 3–5%).
• Heavy Metals:
• The content of heavy metals (e.g., lead) should be within acceptable
limits (e.g., not more than 10 ppm, as per IP requirements).
• Foreign Matter:
• The preparation should be free from extraneous matter and other
contaminants that could affect its stability or efficacy.
6. Storage & Packaging
• Storage Conditions:
• Store in a cool, dry place away from direct sunlight and moisture.
• The container should be tightly closed to prevent moisture ingress and
decomposition.
• Packaging:
• Packaging materials should be compatible with oxidizing agents and
should protect the product during storage and transport.
7. Uses (As per IP Standards)
• Disinfectant and Sanitizer:
• Employed in the disinfection of drinking water, swimming pools, and in
certain industrial applications.
• Bleaching Agent:
• Utilized in bleaching processes in both the textile and paper
industries.
• Other Applications:
• May be used in sanitation and deodorization processes where an
oxidizing agent is required.
Monograph: Sodium Bicarbonate
1. Chemical Information
• Official Name: Sodium Bicarbonate
• Chemical Formula: NaHCO₃
• Molecular Weight: 84.01 g/mol
• CAS Number: 144-55-8
2. Description
• White, crystalline powder.
• Odorless with a slightly alkaline, saline taste.
• Freely soluble in water; sparingly soluble in alcohol.
3. Identification (IP Standards)
• Solubility Test:
• The material should dissolve readily in water to form a clear solution.
• Effervescence Test:
• On addition of a dilute acid (e.g., acetic acid), the sample
effervesces, liberating carbon dioxide, which confirms the presence of the
bicarbonate ion.
• Thermal Decomposition:
• On gentle heating, sodium bicarbonate decomposes to form sodium
carbonate, water, and carbon dioxide. This behavior further aids in its
identification.
4. pH
• A 5% w/v aqueous solution typically exhibits a pH in the range of 8.3
to 8.6, reflecting its weakly alkaline nature.
5. Assay (Purity Test)
• The content of sodium bicarbonate is determined on a dried basis and
should be within the range of 98.0% to 102.0%.
• The assay is generally performed by titrimetric methods, where the
evolved carbon dioxide or the neutralization capacity may be quantified.
6. Impurities & Limits
• Loss on Drying:
• Should not exceed a specified limit (commonly around 0.5%) when
determined at 105°C for a defined period.
• Foreign Matter:
• The material should be free from extraneous matter and other insoluble
impurities.
• Chloride and Heavy Metals:
• Limits for chloride (and any heavy metals, such as lead) are set as per
the IP specifications to ensure safety and quality. (Exact numerical limits should
be verified against the latest IP guidelines.)
7. Storage & Packaging
• Storage Conditions:
• Store in a tightly closed container in a cool, dry place.
• Protection from moisture is essential to prevent the material from
absorbing water or undergoing premature decomposition.
• Packaging:
• Packaging materials should be compatible with the product to maintain
its stability and purity during storage and transit.
8. Uses (As per IP Standards)
• Pharmaceutical Applications:
• Used as an antacid and buffering agent.
• Employed in formulations where mild alkalinity is required, such as in
electrolyte replenishment solutions.
• Other Applications:
• Commonly utilized as a leavening agent in the food industry.
• Used in various industrial applications requiring a source of
carbonate/bicarbonate.
Monograph: Copper Sulphate
1. Chemical Information
• Official Name: Copper(II) Sulphate (typically as the pentahydrate)
• Chemical Formula: CuSO₄·5H₂O
• Molecular Weight: 249.68 g/mol
• CAS Number: 7758-98-7
2. Description
• Appearance: Bright blue crystalline solid with well-formed crystals or
as a blue crystalline powder.
• Odor: Odorless
• Solubility: Freely soluble in water; sparingly soluble in alcohol.
3. Identification (IP Standards)
• Physical Examination:
• The substance must exhibit the characteristic bright blue color
associated with copper(II) sulphate pentahydrate.
• Chemical Tests:
• Sulfate Ion Test: An aqueous solution of the sample, when treated with
barium chloride in the presence of dilute acid, should give a white precipitate of
barium sulphate (BaSO₄), confirming the presence of sulphate ions.
• Copper Ion Test: On acidifying the solution and adding a few drops of
potassium ferrocyanide, a bluish precipitate (copper ferrocyanide) should form,
confirming the presence of copper.
4. Assay (Purity Test)
• Method: Typically determined by titrimetric or gravimetric analysis to
quantify the copper content as copper(II) sulphate pentahydrate.
• Specification: The assay should indicate that the material conforms to
the required content limits (commonly not less than 99.0% on a dried basis).
5. Impurities & Limits
• Loss on Drying:
• Should not exceed the specified limit, accounting for the water of
crystallization inherent in the pentahydrate form.
• Residue on Ignition:
• The ash remaining after ignition must be within the acceptable limits,
ensuring minimal non-volatile impurities.
• Heavy Metals:
• The levels of heavy metals (e.g., lead) should not exceed the limits
specified in the IP (often not more than 10 ppm).
• Other Impurities:
• The sample should be free from extraneous matter that might compromise
its quality and stability.
6. Storage & Packaging
• Storage Conditions:
• Store in a tightly closed container in a cool, dry place, away from
direct sunlight and moisture to preserve the crystalline form.
• Packaging:
• Packaging materials should be inert and provide adequate protection
against moisture and contamination.
7. Uses (As per IP Standards)
• Pharmaceutical Applications:
• Used as a reagent in the preparation of various chemical and
pharmaceutical products.
• May be utilized in topical formulations in very low concentrations,
bearing in mind that internal use is limited due to its toxicological profile.
• Other Applications:
• Employed as a fungicide, algaecide, and in laboratory settings as a
standard reagent.
Monograph: Ferrous Sulphate
1. Chemical Information
• Official Name: Ferrous Sulphate (commonly as the heptahydrate)
• Chemical Formula: FeSO₄·7H₂O
• Molecular Weight: Approximately 278.01 g/mol
• CAS Number: 7782-49-4
2. Description
• Appearance: Typically, ferrous sulphate heptahydrate appears as bluish-
green to greenish crystalline solid; it may also be encountered as a powder.
• Odor: Odorless
• Solubility: Freely soluble in water, forming a greenish solution;
sparingly soluble in ethanol.
• Remarks: The characteristic color is due to the hydrated ferrous ion
and may vary slightly with exposure to air (oxidation).
3. Identification (IP Standards)
• Physical Examination:
• The material should exhibit the characteristic greenish crystalline
appearance of ferrous sulphate heptahydrate.
• Chemical Test for Ferrous Ion:
• 1,10-Phenanthroline Test: An acidified aqueous solution of the sample,
when reacted with an appropriate amount of 1,10-phenanthroline, should develop an
orange-red color due to the formation of the ferrous–phenanthroline complex.
• This color reaction confirms the presence of ferrous ions, which is a
key identification feature of the compound.
4. Assay (Purity Test)
• Method:
• The assay is typically performed on a dried basis using either a
titrimetric method or spectrophotometric analysis (e.g., by measuring the intensity
of the orange-red complex formed with 1,10-phenanthroline).
• Specification:
• The content of ferrous sulphate (expressed as ferrous sulphate
heptahydrate) should not be less than the specified limit (commonly around 98.0% on
a dried basis), in conformity with the IP requirements.
5. Impurities & Limits
• Loss on Drying:
• Should not exceed the limit specified by the IP (e.g., typically not
more than 0.5–1.0% when determined at 105°C for a defined period), accounting for
water of hydration.
• Heavy Metals:
• The levels of heavy metals (e.g., lead) must be within acceptable
limits (commonly not more than 10 ppm) to ensure safety in pharmaceutical
applications.
• Other Impurities:
• The sample should be free from extraneous matter and other contaminants
that could compromise its quality or stability.
6. Storage & Packaging
• Storage Conditions:
• Store in a tightly closed container in a cool, dry place, protected
from moisture and direct sunlight.
• Packaging:
• Packaging materials should be compatible with the compound to avoid any
interaction that might lead to oxidation or degradation.
7. Uses (As per IP Standards)
• Pharmaceutical Applications:
• Employed as an iron supplement in the treatment and prevention of iron
deficiency anemia.
• Used in the preparation of iron formulations where a controlled release
of ferrous ions is required.
• Other Applications:
• Utilized as a reagent in various chemical syntheses and laboratory
procedures.
Monograph: Sodium Thiosulphate
1. Chemical Information
• Official Name: Sodium Thiosulphate (typically as the pentahydrate)
• Chemical Formula: Na₂S₂O₃·5H₂O
• Molecular Weight: Approximately 248.10 g/mol
• CAS Number: 10102-17-7
2. Description
• Appearance: White, crystalline powder; may appear slightly hygroscopic.
• Odor: Odorless
• Solubility: Freely soluble in water; sparingly soluble in alcohol.
3. Identification (IP Standards)
• Physical Examination:
• The substance should exhibit the characteristic white crystalline
appearance.
• Chemical Test:
• Iodometric Reaction: A solution of the sample, when treated with an
excess of iodine in an acidic medium, reduces iodine to iodide, leading to
decolorization of the iodine solution. This reaction confirms the presence of
thiosulphate ions.
• Note: The rapid disappearance of the iodine color upon addition of the
sample is indicative of its reducing properties, which is characteristic of sodium
thiosulphate.
4. Assay (Purity Test)
• Method:
• The assay is typically carried out by an iodometric titration method.
• A measured quantity of sodium thiosulphate is dissolved in water and
reacted with a known excess of standardized iodine solution under acidic
conditions.
• The amount of unreacted iodine is then titrated with a standardized
sodium thiosulphate solution.
• Specification:
• The calculated content, expressed as sodium thiosulphate pentahydrate,
should meet the IP requirements (commonly not less than the stated percentage on a
dried basis).
5. Impurities & Limits
• Loss on Drying:
• Should not exceed a specified limit (typically determined at 105°C for
a defined period) to account for the water of crystallization and ensure minimal
moisture uptake.
• Heavy Metals:
• The levels of heavy metals (e.g., lead) should be within the prescribed
limits (commonly not more than 10 ppm).
• Foreign Matter:
• The sample should be free from insoluble or extraneous matter that may
affect its purity or performance.
6. Storage & Packaging
• Storage Conditions:
• Store in a tightly closed container in a cool, dry place, protected
from moisture.
• Avoid exposure to excessive heat or light, which may affect the
stability of the compound.
• Packaging:
• Packaging should be of material compatible with the substance to
prevent contamination or degradation during storage and transit.
7. Uses (As per IP Standards)
• Pharmaceutical Applications:
• Used as an antidote in cyanide poisoning when administered with
appropriate adjuncts.
• Employed in formulations where its reducing properties are beneficial.
• Other Applications:
• Utilized as a dechlorinating agent in water treatment processes.
• Applied as a reagent in various analytical and photographic processes.