Tricholine Citrate Testing Process

The testing process is divided into two main parts: the Assay Titration and a pH Check preparation.

🧪 TCC Assay Titration Procedure

The assay determines the content of the basic component in Tricholine Citrate using a Non-Aqueous Titration method. TCC acts as a weak base, which is titrated against the very strong acid, HClO4​, in an aprotic solvent like Glacial Acetic Acid.

1. Reagents and Materials

• Sample: Tricholine Citrate (TCC).
• Titrant: 0.1N Perchloric Acid (HClO4​) solution in Glacial Acetic Acid.
• Solvent: Glacial Acetic Acid / Acetic Anhydride mixture (25mL Glacial Acetic Acid + 0.5mL Acetic Anhydride).
  • Note: The note mentions 0.5 mL of TCC instead of Acetic Anhydride, but in this standard assay, it would typically be Acetic Anhydride added to the solvent to suppress the weak basicity of water or to improve the sharpness of the endpoint. Assuming the context of the standard assay, 0.5 mL of a dehydrating agent/catalyst is added.
• Indicator: Crystal Violet (or Methylrosaniline Chloride solution).

2. Titration Steps

1. Sample Preparation: Accurately weigh a specific amount of the TCC sample (indicated as “Weight of sample” in the formula).
2. Solvent Addition: Dissolve the weighed sample in the titration vessel with the solvent mixture (25 mL Glacial Acetic Acid and 0.5 mL of a dehydrating agent/catalyst).
3. Indicator Addition: Add 1-3 drops of Crystal Violet indicator solution.
4. Titration: Titrate the solution against the standardized 0.1 N Perchloric Acid (HClO4​) solution until the endpoint is reached.
5. Endpoint: The titration is complete when the color changes from Violet/Blue (initial color) through Blue-Green to a Clear Yellowish-Green or Light Blue (as noted) which then turns to Emerald Green or Yellow/Brown with excess titrant.
   • The note specifies the color change as: “violet clear change to light blue (excess titrant green colour).” This means the endpoint is reached at the Light Blue stage just before it shifts to the green color of excess perchloric acid.
6. Record Data: Record the volume of 0.1 N HClO4​ consumed (indicated as “Burette Reading (B.R.)” in the formula).

3. Calculation of TCC Assay

The percentage of Tricholine Citrate (TCC) in the sample is calculated using the following formula provided in the notes:

Percentage TCC=Weight of sample×0.1B.R.×0.1×0.01672×100​

Where:

• B.R. = Volume of 0.1 N HClO4​ consumed in the titration (mL).
• 0.1 = Normality of the Perchloric Acid titrant (N). This factor is present in both numerator and denominator and can be simplified out if the titrant is exactly 0.1 N.
• 0.01672 = Equivalent Factor (or millequivalent weight) of Tricholine Citrate.
  • Note: 0.01672 g/mEq corresponds to a molecular weight of 501.45 g/mol for Tricholine Citrate, which is a common value in pharmacopeial assays.
• 100 = Conversion to percentage (%).
• Weight of sample = Weight of the TCC sample taken for the assay (g).
• 0.1 = This likely represents the aliquot factor or a simplification from the standardized procedure, possibly indicating the required amount of base equivalent in the sample.

💧 pH Check Preparation

This section describes a simple preparation step, likely for a pH determination or Limit Test of the TCC solution.

pH Check Procedure

1. Take 100 mL of Distilled Water.
2. Add 5 mL of the Tricholine Citrate (TCC) sample.
3. Mix the solution.
4. The pH of this resulting solution would then be measured using a calibrated pH meter.