Number. 41 batch

Jote 2. We have also carried out this synthesis in ethanol as a solvent but the results were not reproducible. Although a series of experiments with zinc powder from one flask gave reasonable results (50-78% yields), a new flask with the same batch number gave low yields of impure products. The main impurity was probably the non-conjugated diene, H2C=CH-CH2-CH=CH-CH3, possibly resulting from reduction of the 1,2,4-triene by the zinc. The... 

Provide registers for allocating batch numbers, date codes, and other identification data when appropriate. 

Decide who will allocate serial numbers, batch numbers, etc. 

Record the name of the paint manufacturer, the manufacturer s description of each paint used in the system, the reference number and the batch number. 

Ensure that, where possible, paint with the same batch number is used on any particularly identifiable unit of the total job. 

The technology of manufacturing the same basic type or grade of plastics (as with steel and other materials) by different suppliers may not provide the same results. In fact a supplier furnishing their material under an initial batch number could differ when the next batch is delivered and in turn could effect the performance of your product. Taking into account manufacturing tolerances of the plastic, plus variables of equipment and procedure, it becomes apparent that checking several types of materials from the same or from different sources is an important part of material selection and in turn their use. 

Special storage conditions Special precautions about disposal, if applicable Name and address of the marketing authorisation holder Marketing authorisation number Batch number... 

Three different batch sizes were used, namely =400, =800, respectively =1200 kg in the chemical industry it is standard practice to validate a process for the available kettles and then adjust the particular batch size (minimum filling so the stirrer bar remains covered, maximum filling so no overpressure occurs and vents stay free) to achieve the requested tonnage often, campaigns of batches are run before the equipment is cleaned and refitted for the next product, see batch numbers 19. .. 23, followed by 1,. ... ... 

Figure 4.42. Trend analysis over 46 batches of a bulk chemical produced according to the same manufacturing procedure Small and scaled-up batch size [kg], HPLC and Titration assays [%], resp. individual HPLC impurity levels [%], versus batch number. The lack of full correlation between assays indicates that the titration is insensitive to some impurities detected by HPLC. The mass balance, where available, suggests that all relevant impurities are quantified. Impurities B and C, for instance, are highly correlated (r = 0.884, p = 0.0002).

COLUMN 1 Tradename Lichrosorb Functionality C8 Column length 30 cm Particle size 4.0 pm Batch number 2347645 Internal diameter 4.6 mm... 

Lot number, control number, or batch number means any distinctive combination of letters, numbers, or combination of letters, numbers, or symbols, or nay combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined. 

The name, the type and the batch number of the test item should be supplied with the formulation. A GLP (conducted to Good Laboratory Practice) Certificate of Analysis (C of A) detailing the above and also providing confirmation of the amount of active ingredient present in the particular batch of test item to be used in the study should be detailed. This description should include the date of receipt, the amount received. 

The receipt of the test substance should be documented upon arrival at the test site. The name of the product, manufacturer, active ingredient concentration, expiration date, storage location, storage requirements, lot or batch number, the amount received, the condition at receipt, and whether the material is an emulsifiable concentrate (EC), fiowable, powder or otherwise should be noted in the research notebook. In addition, one should note the purchase date, the shipment date, and the carrier of the product. 

One can apply a similar approach to samples drawn from a process over time to determine whether a process is in control (stable) or out of control (unstable). For both kinds of control chart, it may be desirable to obtain estimates of the mean and standard deviation over a range of concentrations. The precision of an HPLC method is frequently lower at concentrations much higher or lower than the midrange of measurement. The act of drawing the control chart often helps to identify variability in the method and, given that variability in the method is less than that of the process, the control chart can help to identify variability in the process. Trends can be observed as sequences of points above or below the mean, as a non-zero slope of the least squares fit of the mean vs. batch number, or by means of autocorrelation.106... 

As in example 1, the explained variance (the total variance minus the residual variance) is calculated by comparing the true process data with estimates computed from a reference model. This explained variance can be computed as a function of the batch number, time, or variable number. A large explained variance indicates that the variability in the data is captured by the reference model and that correlations exist among the variables. The explained variance as a function of time can be very useful in differentiating among phenomena that occur in different stages of the process operations. 

Fig. 37. Score plot of batch polymer reactor data (numbers indicate batch numbers).

Figure 38 shows the variance explained by the two principal component (PC) model as a percentage of each of the two indices batch number and time. The lower set of bars in Fig. 38a are the explained variances for the first PC, while the upper set of bars reflects the additional contribution of the second PC. The lower line in Fig. 38b is the explained variance over time for the first PC and the upper line is the combination of PC 1 and 2. Figure 38a indicates, for example, that batch numbers 13 and 30 have very small explained variances, while batch numbers 12 and 33 have variances that are captured very well by the reference model after two PCs. It is impossible to conclude from this plot alone, however, that batches 13 and 30 are poorly represented by the reference model. 

Fig. 40. -statistics by batch number for k = 1 to 53 minutes for reactor data. 

For some drugs, especially experimental ones, not only is each batch analyzed separately but it can never be combined with other batches. When it is packaged, it is labeled with the batch number and the analysis. For these pharmaceuticals a record must be retained of the complete production history, as well as of the results of all tests. All samples taken from the batch must also be kept. Then, should some odd reaction occur in a patient, all the information about the batch is available to... 

Physical measurements by Schering Corporation are provided for Batch Number UGFP-1961. This batch is chromatographi-cally pure with the exception of 1.1% dechlorogriseofulvin. 

Picture 8.1 Example of containers with manufacturing number (batch number) and a use before date (expire date, in Swedish anv. fore)... 

Batch number R4K21F S6H32E R6M12E2 N970039... 

---