TEST

SPECIFICATION

Description

A pink coloured, round shaped biconvex, tablet plain on both sides.

Identification:

Should comply as per BP

The IR absorption spectrum of the residue should be concordant with the reference spectrum of the ibuprofen

About 75° C

Uniformity of weight

± 5% of average weight

Average Weight

534.00 mg ± 5%

Thickness

4.80 mm (± 0.2 mm)

Diameter

12.80 mm (± 0.2 mm)

Disintegration time

NMT 30 minutes in water medium at 37???

Dissolution

NLT 80% (Q) of LA

Related Substances

Must comply as per BP

Assay of Iuprofen

95.0% to 105.0% of LA

Composition:

Each mL contains: atropine sulfate USP 1 mg, water for injection USP: q s

Category:

Anticholinergic, emergency medications

Indications and usage:

Pre-operative medication to inhibit secretions and salvation, sinus bradycardia, lessen the degree of atrio-ventricular block, antidote for organophosphorous poisoning or choline esters.

Dosage and administration:

Premedication: IV Dose: 0.3 to 0.6 mg immediately before induction of anesthesia and in incremental doses of 0.1 mg for the treatment of bradycardia. IM Dose: 0.3 to 0.6 mg in 30 to 60 minutes before induction.

Muscarinic side effects of neostigmine: IV Dose: 0.6 to 1.2 mg

Bradycardia: IV Dose: 0.3 to 1.0 mg May be repeated if necessary

Organophophorous Poisoning: 2-3 mg parenterally repeat until signs of atropine toxicity

Children: Premedication:0.02 mg/Kg

Dose for resuscitation of neonates, infants and children:0.03 mg/Kg by IV

Adverse effects:

Dry mouth, decreased sweating, constipation, irritation at injection site, difficulty in swallowing, increased sensitivity to light, confusion, skin rash, orthostatic hypotension, loss of memory, headache, nausea, vomiting, tachyacardia, ventricular fibrillation, palpitation, ataxia.

Special precautions:

Reflux oesophagitis, elderly, infants and children, in pregnancy

TEST

SPECIFICATION AS PER USP

Description

A clear colourless solution

Identification

Complies

pH

3.0 to 6.5

Sterility testing

Complies

Volume Variation

NLT 1.0 ml

Bacterial Endotoxin test

NMT 55.6 USP EU/mg of Atropine Sulphate

Particulate Matter

Sample should be free from particles

Assay: Each ml contains: Atropine Sulphate USP 1mg

90.0% to 110.0%

TEST

SPECIFICATION AS PER USP

Description

A clear colourless solution

Identification

Should comply as pr USP

Volume Variation

NLT 1.0 mL

pH

6.9 to 7.9

Particulate Matter

Sample should meet the requirements of  small volume injections

Sterility

Should comply as per USP

Bacterial Endotoxin

NMT 5.8 USP EU/mg of Ketorolac Tromethamine

Assay - Each mL contains: Ketorolac Tromethamine USP - 30mg

90.0% to 110.0%

(27.0 mg - 33.0 mg)

TEST

Limits as per IHS

Description

Black coloured small round shaped biconvex uncoated tablet

Weight of 20 Tablet

9.00 g ± 5%

Average Weight

450.00 mg ± 5%

Uniformity of Weight

± 5.0% of average weight

Thickness

5.20 ± 0.20 mm

Friability

NMT 1.0 %

Diameter

11.50 mm ± 0.20 mm

Hardness

2.0 kg / cm² to 5.0 kg / cm ²

Disintegration Time

NMT 15 min in Purified Water

Microbial Contamination

E coli and Salmonella should be absent

Adsorptive power of Activated Charcoal

The difference between sample and blank titration is 0.7 ml.

Test

In-House Specification

Description

Brown coloured syrup with characteristic odour and taste

pH

4.0 – 6.0

Weight per mL

1.22 g/mL ± 0.03g/mL

Net filled Volume

NLT 100 ml

Leak Test

Must comply

Microbial Test

Total Bacterial Count

NMT 1000 CFU/mL

Total Fungal Count

NMT 100 CFU/ mL

Pathogens:

E. coli

Should be Absent in 1.0 mL

Salmonella

Should be Absent in 10.0 mL

P. aeruginosa

Should be Absent in 1.0 mL

S. aureus

Should be Absent in 1.0 mL

TEST

SPECIFICATION AS PER USP

Description

A clear colourless solution

Identification

(A) HPLC

(B) Colour reaction

(C) Colour reaction

To comply as per BP

A green colour should be produced

A red colour should be produced

Average Volume of 10 containers

NLT 1.0 ml

Colour and Clarity

Clear and colorless solution

pH

2.8 to 3.6

Sterility testing

To be Sterile  

Volume Variation

NLT 1.0 ml

Noradrenaline

NMT 1.0 %

Particulate Matter

Sample should be free from particles

Assay: Each ml contains: Epinephrine Acid Tartarate

Eq to Epinephrine BP 1mg

90.0% to 110.0%

TEST

SPECIFICATION

Description

Clear Colourless Aqueous Solution Filled In Amber Type I Glass Ampoule Having Blue Dot On Neck With Paper Label And Sealed

Identification

IR

UV

Colour Test

Complies  as per BP

Average Volume Of 10 Containers

NMT 1.0 Ml

Colour And Clarity Of Solution

Should Be Clear And Colourless Aqueous Solution

PH

3.7 To 5.5

Hyoscine

Not greater than 0.01%

Related Substance

Complies as per BP

Particulate Matter

Should be free from particulate matter

Sterility Test

To Be Sterile

Assay: Each Ml Contains
Hyoscine Butyl bromide BP

92.5% To 107.5%