The document outlines the preparation, packaging, and evaluation of ascorbic acid injection, detailing necessary ingredients and equipment, followed by a step-by-step preparation procedure. It highlights the stability and safety of the prepared injection through various evaluation tests including physical observation, particulate matter inspection, and leakage tests. The final product is a clear, stable solution stored in sealed ampules, labeled with administration and storage instructions.

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Object: Preparation, Packaging Evaluations and Labelling of Ascorbic Acid Injection.
References:
1. Nahar M, Jain NK. Formulation and Evaluation of Saquinavir Injection. Indian journal of
pharmaceutical sciences. 2006 Sep 1;68(5).
2. Walker SE, Iazzetta J, Law S, Kanji S, Bolduc B, Lamontagne F, Adhikari NK. Administration of
Intravenous Ascorbic Acid—Practical Considerations for Clinicians. Nutrients. 2019 Aug
23;11(9):1994.
3. Pandey, P. Pal, R., & Thakur, S.K. (2023), A textbook of Pharmaceutics-I (Vol. I), JEC
Publications, Page No. 167-172.
Requirements:
• Chemical Requirement: Ascorbic Acid Powder, Sodium Carbonate, Distilled water, Sodium met
bisulfite (Optional as Anti-oxidant agent).
• Glassware/Apparatus: Beaker, Glass rod, Measuring Cylinder, 5 ml Syringe, Glass funnel and
Tripod, Whatmann Filter Paper, 10ml glass Ampules, Digital Weighing Balance, Burner etc.
Theory:
Ascorbic acid (vitamin C) is a water-soluble vitamin essential for various physiological functions in
the body, including collagen synthesis, antioxidant defense, and immune support. Ascorbic acid
injection is used to treat vitamin C deficiencies, such as scurvy, and to provide antioxidant support in
critical care situations like infections or oxidative stress. When administered intravenously, ascorbic
acid bypasses the limitations of oral absorption, leading to higher plasma concentrations. This
injectable form ensures rapid availability and efficacy, especially in cases where oral supplementation
is insufficient or not possible.
Prepared By: Raj Kumar Mandal
B. Pharm 5th
Sem.
ISF College of Pharmacy, Moga, Punjab
Submitted to: Mr. Rahul Pal
*Assistant Professor
Department of Pharmaceutics
ISF College of Pharmacy (ISFCP)
Moga, GT Road, 142001, Punjab, India.

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Procedure:
Preparation of Ascorbic Acid: The preparation of ascorbic acid injection as following flowchart:
Figure 1: Flow Chart for Preparation steps in the preparation of Ascorbic acid injections
➢ Firstly dissolve the weighed amount of ascorbic acid within the distilled water/WFI in 20 ml beaker.
➢ Adding pH adjuster/PBS Solution in order to adjust the pH about 5.5 to 6.5, with slowly added
Na2CO3/NaHCO3
/
NaOH to reduce the effervescent in the beaker to prepare the final solution solving
with continuous stirring via glass rod, (The quality of ingredients as per the Table 1).
➢ The previous prepared solution in the beaker, then filter via using glass funnel and whatman filter
paper with tripod stand.
➢ Additionally, inject the previously filtered injection solution and filled via 5ml syringe into the 5/10
ml glass ampule container at approximately 450
angle.
➢ The filled glass ampules take the open mouth near to the flame and seal by either by pulling or tip
method, depending on everyone. The preparation as per the Fig. 1 as above.
Table 1: List of Ingredient and quantity as per the requirement
Ingredient Range Required Quality
(Upto 10 ml)
Properties
Ascorbic Acid Powder 100-500 mg/ml 1 gm API
Sodium Carbonate I.P 2-5 mg/ml 100 mg pH adjuster
Distilled Water Q.S. 10-15 ml Solvent

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Evaluation of Prepared Ascorbic Acid Injection
1. Physical Observation: The physical appearance of the prepared ascorbic acid injection was
assessed visually. The solution appeared clear and colorless when observed under normal lighting
conditions. No signs of discoloration, turbidity, or visible degradation were detected, indicating
that the ascorbic acid remained stable during formulation. Maintaining the clear and colorless
nature of the solution is essential for ensuring the quality and purity of the injectable product.
2. Particulate Matter Checking Test: The prepared injection was visually inspected for the
presence of particulate matter. No visible particles were observed when the solution was held up
against a light source. This suggests that the preparation process was effectively sterile and free
from contaminants, ensuring the product's safety and compliance with pharmaceutical standards
for injectable solutions.
3. Sealing/Leakage Test: To evaluate the integrity of the sealed vials, a leakage test was conducted.
Each vial was submerged into a field of water and closely monitored for the formation of bubbles,
which would indicate a leak. No bubbles were observed during the test, confirming that the vials
were properly sealed and that the container closure system was intact. This is crucial to maintaining
sterility and preventing contamination of the product. The label ascorbic acid injection as
following.
Product Name Ascorbic Acid Injection
Ingredients Ascorbic Acid, Sodium Carbonate, Distilled
Water/WFI
Directions for Use To be given by or under the Direct supervision of
doctors or RMP.
Storage Store in a cool, dry place, away from direct
sunlight
Net Weight 5ml/ampule
Manufacturing Date 07/Oct./2024
Expiry Date 07/Oct./2025
Manufactured By ISF Lab Industrial Pharmacy 149.

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The prepared ampules of ascorbic acid visibility by physical observation as following:
Figure 2: Preparation of Ascorbic Acid Injection
Results and Discussion
The 5 mL ascorbic acid injection was successfully formulated and submitted to the laboratory and
evaluated. The formulation process adhered to standard sterile preparation techniques, ensuring the
stability and sterility of the product.
On evaluation of prepared injection of ascorbic acid, by looking physically through naked eyes
colour yellowish white obtained in the ampules, and the turbidity was evaluated clearly
transparent. The leakage test passed on dipping into water no bubble formed which assured no
leakage in the sealed ampules.