Application scheme of Digipol-P610 multi-wavelength high speed optical rotation test

I. Introduction

In the field of pharmaceutical research and development and production, especially when involving new synthetic drugs, some drugs have weak rotation under the 589nm standard sodium light source, which is difficult to accurately detect. In order to meet the standards of international pharmacopoeia and meet the needs of drug export inspection, multi-wavelength high-speed poltometer has become an inevitable choice for many pharmaceutical companies. With advanced technology and rich functions, Digipol-P610 of Shanghai Jiahang Instrument Co., Ltd. can efficiently and accurately complete the task of drug specific rotation detection.
2. Experiment preparation

2.1 Test equipment

1.Digipol-P610 automatic digital politerator

2. Supporting temperature control test tube,

3. High precision electronic balance (accuracy of 1/10,000)

4.100mL volumetric bottle.

Digipol-P610 automatic digital politrotometer has a stable optical system and accurate detection components to ensure the reliability of measurement data; High precision electronic balance can accurately weigh the sample quality; The 100mL volumetric bottle is used to accurately prepare sample solutions.

2.2 Experimental reagents

1. Ertapenem (antibiotic)

2. Sulfonamide chlorpyridazine sodium (antibiotic)

3. Iopanol (injection)

4. Finasteride (hormone drug)

5. All kinds of drug supporting solvents

3. Experimental steps
3.1 Sample Test

1. According to USP, ESP, JSP pharmacopoeia standards, use high-precision electronic balance to accurately weigh the right amount of samples. First, put the sample in a small beaker and dissolve it with a small amount of the corresponding solvent. After ensuring that the sample is completely dissolved, transfer the solution carefully to a 100mL volumetric bottle, and then fill it with the solvent to the volumetric bottle line, shake it well, mix the solution evenly, and set aside.

2. Connect the power source of Digipol-P610 automatic digital optical polator and turn on the instrument. Select the appropriate light source wavelength according to the requirements of the pharmacopoeia on the operation interface, let the instrument preheat for 5-10 minutes, so that the instrument reaches a stable working state and ensures the measurement accuracy.

3. Adjust the test mode to the specific curl mode through the instrument operation interface. According to the actual sample concentration, the concentration parameters are accurately set on the instrument; Depending on the tube specification used, set the tube length to 100mm.

4. Take the matching temperature control test tube, rinse with blank solvent 2-3 times, and inject blank solvent. Put the temperature-controlled test tube with blank solvent into the sample room of the instrument smoothly, and click the "Clear" button on the instrument operation interface to eliminate the influence of the solvent itself on the measurement results.

5. Take out the temperature-controlled test tube, pour out the blank solvent, and wash the test tube with the prepared sample 2-3 times to ensure that the residual solution in the test tube will not affect the sample measurement. Then use a syringe to absorb an appropriate amount of the sample and slowly inject it into the temperature-controlled test tube to avoid bubbles.

6. Put the test tube into the sample chamber, insert the temperature probe correctly into the constant temperature test tube, set the temperature at 25℃ on the instrument operating interface, and open the temperature control button to start the temperature control function. After the sample temperature is stable, click the "Test" button, the instrument will automatically measure and read the specific rotation of the sample.

3.2 Sample calculation

Jiahang
Where: α is the rotatory power, [a]D25 represents the specific rotatory constant at 25℃, c is the mass concentration (g/ml), and L is the length of the rotatory tube (dm). In the actual calculation, the measured rotatory α, the prepared mass concentration c and the tube length L are substituted into the formula, and the specific rotatory of the sample can be accurately calculated.

4. Results and discussion
The Digipol-P610 fully automatic digital politer is equipped with an intuitive LCD display and a simple and easy to understand interface. During the test process, key parameters such as concentration, tube length, measurement times and measurement mode can be displayed in real time. After the measurement is complete, the measurement results are clearly displayed on the interface, and the data storage, printing, and transmission functions are also supported. Users can choose different measurement modes on the interface according to their needs, such as general mode, GMP mode, etc., and can also customize measurement parameters to meet diversified test needs.

4.1 Application situation

4.3 Instrument Introduction

The Digipol-P610 automatic digital poltometer is standard with a variety of commonly used wavelengths, such as 546nm and 589nm, and can be selected according to user needs 365nm, 405nm, 436nm, 578nm, 633nm and other wavelengths to meet the wavelength requirements of different drug detection. The instrument adopts advanced digital processing technology, which greatly improves the measurement accuracy, repeatability and reliability. The high-speed measurement function can significantly improve the test efficiency and effectively shorten the sample measurement time. The instrument complies with relevant standards such as national Pharmacopoeia, GMP, GLP and FDA/21CFR 11. It has functions such as user classification management, electronic signature, password management, network transmission, data protection and traceability, and has a large-capacity database, which is convenient for users to save, transmit, print and trace measurement data. It also allows users to define and pre-store common measurement methods, which is convenient and efficient.