3

Master Formula 1

Formula Title Isoniazid suspension

Formula Number 1 Quantity Prepared 1000 ml
Strength of Formula 1.6% Dosage Form suspension

Ingredient Quantity (%W/W) Unit Calculation/Comment

Isoniazid 14 gm active ingredients
Citric acid monohydrate 2.5 gm Buffering agent
Sodium citrate 12.0 gm Buffering agent
Concentrated anise water 10 ml flavoring agent
Compound tartazine solution 10 ml coloring agent
Glycerol 200 ml sweetening agent/ suspending agent
Sorbitol 300 ml sweetening agent/ suspending agent
Conc.paraben 10 ml preservative
EDTA 0.01 ml chelating agent
Sodium metabisulfite 5 ml antioxidant
Water qs. to 1000 ml solvent

EQUIPMENT REQUIRED:
1. Conical graduate
2.
 4

3.
4.
5.
6.
7.
8.
9.
10.

COMPOUNDING INSTRUCTIONS:
1.

2. INH
3. Citric acid monohydrate , Sodium citrate Sodium metabite sulfite
INH
4. Sorbitol , glycerol
5. Conc.paraben, EDTA
6. Concentrated anise water Compound tartazine solution
7.
8. Purified water 1000 ml

WORKING SHEET 1
Isoniazid suspension 60 ml
Working Formula 1
Formula Title Isoniazid suspension
 5

Formula Number 1 Quantity Prepared 60 ml

Strength of Formula 1.6% Dosage Form suspension
LAST UPDATE ___28 /01/52 BATCH NO._________RX462406-01

INGREDIENT QUANTITY MEASURED CHECKED

Isoniazid 0.84 gm 0.84 gm
Citric acid monohydrate 0.15 gm 0.15 gm
Sodium citrate 0.72 gm 0.72 gm
Concentrated anise water 0.60 ml 0.60 ml
Compound tartazine solution 0.60 ml 0.60 ml
Glycerol 12.00 ml 12.00 ml
Sorbitol 18.00 ml 18.00 ml
Conc.paraben 0.60 ml 0.60 ml
EDTA 0.0006 ml 0.0006 ml
Sodium metabisulfite 0.30 ml 0.30 ml
Water qs. to 60.00 ml 60.00 ml

Formula Title Concentrated anise water

Formula Number 1 Quantity Prepared 20 ml

INGREDIENT QUANTITY MEASURED CHECKED

Anise oil 0.04 ml 0.04 ml
Citric acid monohydrate 14 ml 14 ml
Water qs. to 20 ml 20 ml
 6

EQUIPMENT REQUIRED:
1. Conical graduate
2.
3.
4.
5.
6.
7.
8.
9.
10.

COMPOUNDING INSTRUCTIONS:
1.

2. INH
3. Citric acid monohydrate , Sodium citrate Sodium metabite sulfite
INH
4. Sorbitol , glycerol
5. Conc.paraben, EDTA
6. Concentrated anise water Compound tartazine solution
7.
8. Purified water 60 ml
 7

EXPIRY : 14
STORAGE :

SAMPLE LABEL:

Isoniazid suspension 60 ml

..

1 1

( 2-8C)

DATE AND SIGNATURE (TECHNICIAN AND PHARMACIST FINAL CHECK)

Quality Control Tests:

pH 6
 8

Master Formula 2
Formula Title Isoniazid suspension
Formula Number 2 Quantity Prepared 1000 ml
Strength of Formula 1.6% Dosage Form suspension

Ingredient Quantity (%W/W) Unit Calculation/Comment

Isoniazid 14 gm active ingredients
Citric acid monohydrate 2.5 gm Buffering agent
Sodium citrate 12.0 gm Buffering agent
Concentrated anise water 10 ml flavoring agent
Compound tartazine solution 10 ml coloring agent
Glycerol 200 ml sweetening agent/ suspending agent
Methylcellulose 15 10 g suspending agent
Sorbitol 300 ml sweetening agent/ suspending agent
Conc.paraben 10 ml preservative
EDTA 0.01 ml chelating agent
Sodium metabisulfite 5 ml antioxidant
Water qs. to 1000 ml solvent
 9

EQUIPMENT REQUIRED:
1. Conical graduate
2.
3.
4.
5.
6.
7.
8.
9.
10.

COMPOUNDING INSTRUCTIONS:
Methylcellulose
1. Methylcellulose 0.5 g 70 50 ml
Methylcellulose
2. Methylcellulose Mucilage 1%

1.

2. INH
3. Citric acid monohydrate , Sodium citrate Sodium metabite sulfite
INH
4. Sorbitol , glycerol
5. Conc.paraben, EDTA
 10

6. Concentrated anise water Compound tartazine solution

7.
8. Purified water 60 ml

WORKING SHEET 2
Isoniazid suspension 60 ml
Working Formula 2
Formula Title Isoniazid suspension
 11

Formula Number 2 Quantity Prepared 60 ml

Strength of Formula 1.6% Dosage Form suspension
LAST UPDATE ___28 /01/52 BATCH NO._________RX462406-02
INGREDIENT QUANTITY MEASURED CHECKED
Isoniazid 0.84 gm 0.84 gm
Citric acid monohydrate 0.15 gm 0.15 gm
Sodium citrate 0.72 gm 0.72 gm
Concentrated anise water 0.60 ml 0.60 ml
Compound tartazine solution 0.60 ml 0.60 ml
Glycerol 12.00 ml 12.00 ml
Methylcellulose 15 0.60 ml 0.60 ml
Sorbitol 18.00 ml 18.00 ml
Conc.paraben 0.60 ml 0.60 ml
EDTA 0.0006 ml 0.0006 ml
Sodium metabisulfite 0.30 ml 0.30 ml
Water qs. To 60.00 ml 60.00 ml
Formula Title Concentrated anise water
Formula Number 2 Quantity Prepared 20 ml

INGREDIENT QUANTITY MEASURED CHECKED

Anise oil 0.04 ml 0.04 ml
Citric acid monohydrate 14 ml 14 ml
Water qs. to 20 ml 20 ml
 12

EQUIPMENT REQUIRED:
1. Conical graduate
2.
3.
4.
5.
6.
7.
8.
9.
10.

COMPOUNDING INSTRUCTIONS:
Methylcellulose
1. Methylcellulose 0.5 g 70 50 ml
Methylcellulose
2. Methylcellulose Mucilage 1%

1.

2. INH
3. Citric acid monohydrate , Sodium citrate Sodium metabite sulfite
INH
 13

4. Sorbitol , glycerol
5. Conc.paraben, EDTA
6. Concentrated anise water Compound tartazine solution
7.
8. Purified water 60 ml

EXPIRY : 14
STORAGE :

SAMPLE LABEL:

Isoniazid suspension 60 ml

..

1 1

( 2-8C)

DATE AND SIGNATURE (TECHNICIAN AND PHARMACIST FINAL CHECK)

Quality Control Tests:

pH 6
 14

INH
 15

Isoniazid (BAN, pINN)

: INAH; INH; isonicotinic acid hydrazide; isonicotinoylhydrazine; isonicotinylhydrazide;

isonicotinylhydrazine; tubazid Isonicotinohydrazide; 4-pyridinecarboxylic acid hydrazide
: C6H7N3O
: 137.1
: ,
:

pH : 5 % solution of isoniazid in water 6-8, 10 % solution of isoniazid in water 6-
7.5, 1 % solution of isoniazid 5.5-6.5
(Dissociation constants) : pKa 1.8 (hydrazine nitrogen), 3.5 (pyridine nitrogen), 10.8
(acidic group)
(Partition coefficient) : Log P (octanol/pH 7.4), - 11
(Solubility) : Isoniazid 1 8 , 45 ,
1000
 16

(Dissolution) : USP Isoniazid USP C6H7N3O

80% 45 0.1 N HCl 900 mL
100 rpm
(Incompatibility/compatibility) : Isoniazid ,
reducing sugars isonicotinoyl hydrazones ( Isoniazid
reducing sugars ) Isoniazid ( Bioavailability)
hydrazones hydrolysed

Isoniazid chloral, iodine, hypochlorites, ferric salts

oxidizing agents Isoniazid magnesium
oxide Wu

Anise Oil
 17

Anise Oil is the volatile oil distilled with steam from the dried,ripe fruit of Pimpinella ansiumL.
(Fam.Apiaceae)or from the dried ripe fruit of Illicium verumHook.f.(Fam.Illiciaceae).
NOTEIf solid material has separated,carefully warm the Anise Oil until it is completely liquefied,and
mix before using.
Packaging and storage Preserve in well-filled,tight containers,and avoid exposure to excessive heat.
Labeling The label states the Latin binomial name and,following the official name,the part of the plant
source from which the article was derived.The label also states that if solid material has
separated,carefully warm oil until it is completely liquefied,and mix before using.
Solubility in 90percent alcohol One volume dissolves in 3volumes of 90percent alcohol.
Specific gravity : between 0.978and 0.988.
Congealing temperature: not lower than 15.
Angular rotation : between 2 and +1.
Refractive index : between 1.553and 1.560at 20.
Heavy metals,Method : 0.004%.
Limit of phenolsAsolution of recently distilled Anise Oil in 90percent alcohol (1in 3)is neutral to
moistened litmus paper,and the solution develops no blue or brownish color upon the addition of 1drop of
ferric chloride TSto 5mLof the solution.
: Flavoring agent

Edetic acid

: Dissolvine; edathamil; EDTA; ethylenediaminetetraacetic acid;

(ethylenedinitrilo)tetraacetic acid; Sequestrene AA; tetracemic acid; Versene Acid.
: N,N-1,2-Ethanediylbis[N-(carboxymethyl)glycine] [60-00-4]
: C10H16N2O8
: 292.24
:
: Chelating agent
 18

Glycerol

: Glycerin
: propane-1,2,3-triol [56-81-5]
: C3H8O3
: 92.09
: 0.6

: sweetening agent/ suspending agent

Methylparaben

: E218; 4-hydroxybenzoic acid methyl ester; methyl p-hydroxybenzoate

: Methyl-4-hydroxybenzoate [99-76-3]
: C8H8O3
: 152.15
:

: Antimicrobial preservative
 19

Propylparaben

: E216; 4-hydroxybenzoic acid propyl ester; propagin; propyl p-hydroxybenzoate

: Propyl 4-hydroxybenzoate [94-13-3]
: C10H12O3
: 180.20
:
: Antimicrobial preservative

Purified water

: Aqua; hydrogen oxide

: Water [7732-18-5]
: H2O
: 18.02
: ,
: Vehicle

Sodium metabisulfite
 20

: Disodium disulfite; disodium pyrosulfite; disulfurous acid, disodium salt; E223; natrii
disulfis; sodium acid sulfite; sodium pyrosulfite
: Sodium pyrosulfite [7681-57-4]
: Na2S2O5
: 190.1
: sulfur
dioxide
: Antioxidant

Sodium Citrate Dihydrate

: Citric acid trisodium salt; E331; sodium citrate tertiary; trisodium citrate.
: Trisodium 2-hydroxypropane-1,2,3-tricarboxylate dihydrate [6132-04-3]
: C6H5Na3O72H2O
: 294.10
: sulfur
dioxide
: Antioxidant

Sorbitol

: 1,2,3,4,5,6-hexanehexol
 21

: D-Glucitol [50-70-4]
: C6H14O6
: 182.17
:
: sweetening agent/ suspending agent

Isoniazid extemporaneous
preparations Isoniazid 100mg/tablet
Isoniazid Isoniazid hydrolysis
oxidation aerobic Isoniazid 1% pH 6 pH 3
37 pH buffer
Citric acid monohydrate Sodium citrate
Isoniazid , reducing
sugars isonicotinoyl hydrazones
aqueous
solution sucrose glucose fructose Isoniazid
condensation complex oxidation, hydrolysis inversion
isonicotinyl hydrazone reducing sugar sodium citrate (0.3%)
hydrolysis sucrose
sodium citrate (0.3%) browning reaction
Isoniazid lactose wet granulation
tropical subtropical Isoniazid lactose 10-20%
Isoniazid lactose isonicotinoyl hydrazone freshly prepared
lactose Isoniazid lactose 1-3% Isoniazid
Isoniazid
Isoniazid pH 3
Isoniazid
wet wetting agent wet
Methylcellulose 15 Sorbitol
 22

order of mixing
Methylcellulose 15 Sorbitol
Methylcellulose 15
Glycerol
second suspending agent true suspending agent
Methylcellulose 15
Antimicrobial preservative antioxidant Chelating agent

 23

1
isoniazid
1
1 70 5
1 60
12 3

1 ( )
3

60
2 3

1 60 ml
:

1. C Rowe R, Sheskey PJ, Owen SC. The handbook of pharmaceutical
excipients. London: Pharmaceutical Press; 2004.
 24

2. Lund W. The pharmaceutical codex. 12th ed. London: Pharmaceutical Press;

1994.

3. USP28/NF23. USA: United States pharmacopeial Convention, Inc.

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